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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K964614
Device Name ULTRAFERA WOUND DRESSING
Applicant
AMERICAN WHITE CROSS, INC.
349 LAKE RD.
DAYVILLE,  CT  06241
Applicant Contact PAUL B CALLAHAN
Correspondent
AMERICAN WHITE CROSS, INC.
349 LAKE RD.
DAYVILLE,  CT  06241
Correspondent Contact PAUL B CALLAHAN
Regulation Number880.5090
Classification Product Code
KMF  
Subsequent Product Code
EFQ  
Date Received11/18/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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