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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K861215
Device Name GAUZE SPONGES USP TYPE VII
Applicant
Selomas, Inc.
Seton Center
950 Forge Ave.
Norristown,  PA  19403
Applicant Contact KENNETH E CLEAVER
Correspondent
Selomas, Inc.
Seton Center
950 Forge Ave.
Norristown,  PA  19403
Correspondent Contact KENNETH E CLEAVER
Classification Product Code
EFQ  
Date Received03/31/1986
Decision Date 04/17/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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