FDA 510(k) Premarket Notification K122391: MEDTRONIC XOMED, INC.

Submission Details & Decision

Normalized public record details for 510(k) notification K122391.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K122391

Applicant / Sponsor

Medtronic Xomed, Inc.

Device Name

MEDTRONIC XOMED, INC.

Product Code

LRK

Decision Date

2013-01-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2012-08-07

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
Great Lakes Dental Technologies, Ltd. Registration: 1316408 View Registration
IRONWOOD INDUSTRIES, INC. Registration: 1420088 View Registration
RANIR LLC Registration: 1825660 View Registration
Ortho Solutions LC Registration: 1937100 View Registration
LIFE SCIENCE OUTSOURCING, INC. Registration: 2031093 View Registration
SPACE MAINTAINERS LAB Registration: 2082148 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
DENTAL PROSTHETIC SERVICES, INC. Registration: 3000171384 View Registration
LABORATORIOS DENTALES DE ZONA FRANCA, S.A. Registration: 3001295407 View Registration
DRAKE PRECISION DENTAL LABORATORY, INC. Registration: 3002706372 View Registration
GLOBAL DENT AIDS PRIVATE LIMITED Registration: 3002911411 View Registration
BRAEBON MEDICAL CORP. Registration: 3002912391 View Registration
GREEN DENTAL LAB Registration: 3002916277 View Registration
Splintek Inc. Registration: 3003460151 View Registration
AIRWAY MANAGEMENT INC. Registration: 3003496134 View Registration
MYERSON LLC Registration: 3003928050 View Registration
R-DENT DENTAL LABORATORY, INC Registration: 3004038575 View Registration
HEXA CERAM CO., LTD. Registration: 3004748290 View Registration
NEW IMAGE DENTAL LABORATORY, INC. Registration: 3004860162 View Registration
DAVIS DENTAL LAB Registration: 3004935484 View Registration
ADVANCED BRAIN MONITORING, INC. Registration: 3004964738 View Registration
SOMNOMED, LTD. Registration: 3005343849 View Registration
SOMNOMED INC. Registration: 3005598536 View Registration
BIOTEX, INC. Registration: 3005726841 View Registration
Oral Arts Laboratory, Inc. Registration: 3005730680 View Registration
Tomed GmbH Registration: 3006038700 View Registration
SICAT GMBH & CO. KG Registration: 3006098230 View Registration
KELLER LABORATORIES Registration: 3006650414 View Registration
Innovative Health Technologies (NZ) Limited Registration: 3006786034 View Registration
Sleep Science Partners, Inc. Registration: 3006794225 View Registration
TRUE FUNCTION LABORATORY INC Registration: 3007108578 View Registration
Burbank Dental Laboratory Registration: 3007233968 View Registration
MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 Inc. Registration: 3007616887 View Registration
SHUN HSIANG PLASTIC CO.,LTD. Registration: 3008102163 View Registration
ZEPEDA DENTAL LAB Registration: 3008159012 View Registration
GCDL, LLC Registration: 3008186372 View Registration
GERGENS ORTHODONTIC LAB Registration: 3008274496 View Registration
AMERICAN SLEEP DENTISTRY Registration: 3008313791 View Registration
THE SNORE RELIEVER COMPANY Registration: 3008583502 View Registration
XIAMEN YIZHOU IMP. & EXP. CO., LTD. Registration: 3008763803 View Registration
SLEEPING WELL, LLC Registration: 3008797926 View Registration
M R UTILITY PRODUCTS PRIVATE LIMITED Registration: 3008808087 View Registration
SLEEP JOY INTERNATIONAL LLC Registration: 3009132214 View Registration
ARTISAN LABORATORIES INC Registration: 3009401301 View Registration
SomnoMed Phillipines Inc. Registration: 3009440973 View Registration
INVENTEX MEDICAL Registration: 3009495876 View Registration
ALWAYS MORE MARKETING INC Registration: 3009549313 View Registration
APNEA SCIENCES CORPORATION Registration: 3009549393 View Registration
PANTHERA DENTAL INC Registration: 3009779268 View Registration
Modern Dental International Trading Limited Registration: 3010022489 View Registration
CRANE DENTAL LABORATORY Registration: 3010324114 View Registration
The Metz Dental Laboratory Registration: 3010347083 View Registration
Koncept Innovators, LLC Registration: 3010358861 View Registration
Boyd Research Registration: 3010767848 View Registration
ADVANTECH PLASTICS, LLC Registration: 3010852338 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
ORTHOAPNEA S.L. Registration: 3012359952 View Registration
Open Airway Dental Solutions Australia Pty Ltd Registration: 3012539501 View Registration
APEX DENTAL SLEEP LAB Registration: 3012716038 View Registration
DIAMOND ORTHOTIC LABORATORY, LLC Registration: 3012728846 View Registration
PROSOMNUS SLEEP TECHNOLOGIES Registration: 3013116677 View Registration
ZHUHAI DS DENTAL TECHNOLOGY CO., LTD Registration: 3013156109 View Registration
Quality Packaging Specialists International, LLC Registration: 3013445151 View Registration
ONIRIS Registration: 3013548547 View Registration
SMARTGUARD RX INC Registration: 3013652641 View Registration
IDOC DENTAL LAB Registration: 3013934196 View Registration
Modern Dental Laboratory (DG) Co., Ltd. Registration: 3013950969 View Registration
JOHNS DENTAL LABORATORY Registration: 3014680794 View Registration
DOC BRANDS, INC. Registration: 3015128224 View Registration
HONGKONG LOYAL BEAUTY TECHNOLOGY LIMITED Registration: 3015169722 View Registration
Modern Dental Global Solutions Limited Registration: 3015674959 View Registration
SHINRIN-YOKU TRADERS LLC Registration: 3015989643 View Registration
SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD. Registration: 3016674860 View Registration
APNOMED, INC. Registration: 3017092365 View Registration
Slow Wave, Inc. Registration: 3017520337 View Registration
3DPX MEDICAL Registration: 3017567754 View Registration
NEWSOM Registration: 3017927175 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Serena Sleep Registration: 3018783197 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD Registration: 3021282544 View Registration
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Vivos Therapeutics INC. Registration: 3022315836 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
COMFORT ACRYLICS, INC. Registration: 3025124 View Registration
SOLBARO CO.,LTD. Registration: 3025306497 View Registration
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SNORELESSNOW LLC Registration: 3027579589 View Registration
REAZEAL CORP Registration: 3028271666 View Registration
AIOMEGA, LLC Registration: 3030562551 View Registration
GELB PRACTICE Registration: 3030914478 View Registration
GOOD SLEEP CO USA LLC Registration: 3031282374 View Registration
SLEEPCARE, LLC Registration: 3031288631 View Registration
FISSIONTECH LLC Registration: 3031978086 View Registration
DONGGUAN YIYAO SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. Registration: 3038209294 View Registration
SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD. Registration: 3039443708 View Registration
EMA-SLEEP INC Registration: 3039643908 View Registration
QuietLab LLC Registration: 3043364471 View Registration
The Myerson Company Limited Registration: 8010019 View Registration
OSCIMED SA Registration: 9614473 View Registration
AURUM CERAMIC DENTAL LABORATORIES LTD. Registration: 9615291 View Registration

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