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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 K852412
Device Name NON-ADHERENT PAD
Applicant
American White Cross, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
American White Cross, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Classification Product Code
EFQ  
Date Received06/06/1985
Decision Date 07/29/1985
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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