FDA 510(k) Premarket Notification K842601: PRE-OPERATIVE OPHTHALMIC DRESSING TRAY

Submission Details & Decision

Normalized public record details for 510(k) notification K842601.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K842601

Applicant / Sponsor

Ophthalmic Resources, Inc.

Device Name

PRE-OPERATIVE OPHTHALMIC DRESSING TRAY

Product Code

HOZ

Decision Date

1985-05-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

1984-07-05

Related Establishments / Registrations

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
INVOTEC INTERNATIONAL, INC. Registration: 1052728 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
RUMEX INTERNATIONAL CO. Registration: 1058726 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
HURRICANE MEDICAL Registration: 1064005 View Registration
Beaver-Visitec International, Inc. Registration: 1211998 View Registration
MEDTRONIC XOMED, INC. Registration: 1219071 View Registration
CARWILD CORP. Registration: 1219313 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
AMERICAN SURGICAL COMPANY, LLC Registration: 1221144 View Registration
PROFESSIONAL CONTRACT STERILIZATION, INC. Registration: 1222313 View Registration
Microspecialties LLC Registration: 1226074 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
ANODYNE SURGICAL Registration: 1929756 View Registration
Sterigenics U.S., LLC Registration: 2022435 View Registration
BIOSEAL Registration: 2027062 View Registration
EAGLE LABS, LLC Registration: 2027619 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
OASIS MEDICAL, INC. Registration: 2083373 View Registration
MED-LOGICS, INC. Registration: 2085081 View Registration
L&R USA INC. Registration: 2135152 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
KATENA PRODUCTS, INC. Registration: 2242450 View Registration
VISCOT MEDICAL LLC Registration: 2242656 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
DUKAL LLC Registration: 2435946 View Registration
Alcon Research, LLC Registration: 2523835 View Registration
MED SAVER, INC. Registration: 2529846 View Registration
NETWORK MEDICAL PRODUCTS, LTD. Registration: 3001967056 View Registration
LOHMANN & RAUSCHER GMBH & CO. KG Registration: 3002468342 View Registration
M/S TARUN ENTERPRISES Registration: 3003951061 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration
ATLANTA HEALTHCARE SERVICES Registration: 3005391805 View Registration
Ambler Surgical, LLC Registration: 3005528784 View Registration
Oasis Medical, Inc. Registration: 3006234743 View Registration
HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. Registration: 3007735241 View Registration
SUMMIT MEDICAL LLC Registration: 3008719017 View Registration
Swann-Morton(Services) Limited Registration: 3008812251 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
AEGIS LIFESCIENCES PRIVATE LIMITED Registration: 3009403363 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
TECFEN MEDICAL Registration: 3010487482 View Registration
CENEFOM CORP Registration: 3010610457 View Registration
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3010807315 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
WELL SUN OPTICAL TECHNOLOGY LIMITED. Registration: 3011164728 View Registration
RUMEX Baltics SIA Registration: 3012185136 View Registration
SANICURE BV Registration: 3012494290 View Registration
YILMAZ BIO MEDIKAL Registration: 3012620142 View Registration
WENZHOU DUOLA TRADE CO., LTD. Registration: 3013004948 View Registration
Beaver-Visitec International, Inc. Registration: 3013421458 View Registration
Grupo American Industries, S.A. de C.V Registration: 3013466775 View Registration
KATENA PRODUCTS, INC. Registration: 3015177648 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
SAINT JONES MANAGEMENT LP EOOD Registration: 3016904853 View Registration
QUESTALPHA GmbH & Co. KG Registration: 3017475063 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
MICROSURGICAL TECHNOLOGY, INC. Registration: 3019924 View Registration
OCCUTECH CO., LTD. Registration: 3020775387 View Registration
EON MEDITECH PVT. LTD. Registration: 3023464160 View Registration
READY SET IMPORT Registration: 3024088964 View Registration
Perfect Ophthalmic Instruments FZE Registration: 3031231776 View Registration
AKRITI OPHTHALMIC PRIVATE LIMITED Registration: 3042228518 View Registration
WENZHOU EASY & LUCKY OPTICAL TRADE CO., LTD. Registration: 3042284339 View Registration
BOEN HEALTHCARE CO., LTD. Registration: 3045058049 View Registration
SHENZHEN JPY ION-TECH. CO., LTD. Registration: 8043396 View Registration
LOHMANN & RAUSCHER GMBH & CO. KG Registration: 9611462 View Registration
MEDSORB DOMINICANA, S.A. Registration: 9680271 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.