FDA 510(k) Premarket Notification K861444: S1 NASAL PACKING

Submission Details & Decision

Normalized public record details for 510(k) notification K861444.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K861444

Applicant / Sponsor

Surgical Specialties, Inc.

Device Name

S1 NASAL PACKING

Product Code

EFQ

Decision Date

1986-05-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

1986-04-17

Related Establishments / Registrations

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ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
MEDTRONIC XOMED, INC. Registration: 1219071 View Registration
CARWILD CORP. Registration: 1219313 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
MCNEIL HEALTHCARE LLC Registration: 1223924 View Registration
HYDROFERA, LLC. Registration: 1225532 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Cardinal Health Registration: 1921846 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
CERTIFIED SAFETY MFG., INC. Registration: 1932902 View Registration
PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
A PLUS INTERNATIONAL, INC Registration: 2083545 View Registration
VISCOT MEDICAL LLC Registration: 2242656 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
DUKAL LLC Registration: 2435946 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
DERMA SCIENCES NANTONG INCORPORATION Registration: 3003636207 View Registration
DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration
ALLMED MEDICAL PRODUCTS CO., LTD. Registration: 3004950768 View Registration
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CHANGZHOU ATOMIC HI-TECH RADIATION CO., LTD. Registration: 3006636956 View Registration
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HYDROFERA, LLC. Registration: 3019543072 View Registration
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MEDSORB DOMINICANA, S.A. Registration: 9680271 View Registration
SUZHOU AVON TEXTILE CO., LTD. Registration: 9680455 View Registration

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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.