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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 K905136
Device Name GAUZE SPONGES, INTERNAL AND EXTERNAL
Applicant
American Healthcare Corp.
30 Craig St.
Brantford, Ontario N3t 5m9
Canada,  CA
Applicant Contact CAROL MASON
Correspondent
American Healthcare Corp.
30 Craig St.
Brantford, Ontario N3t 5m9
Canada,  CA
Correspondent Contact CAROL MASON
Classification Product Code
EFQ  
Date Received11/15/1990
Decision Date 03/06/1991
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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