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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K894802
Device Name AWC BUTTERFLY WOUND CLOSURES
Applicant
AMERICAN WHITE CROSS, INC.
BOX L
NEW ROCHELLE,  NY  10802
Applicant Contact JACK ORENTZEL
Correspondent
AMERICAN WHITE CROSS, INC.
BOX L
NEW ROCHELLE,  NY  10802
Correspondent Contact JACK ORENTZEL
Regulation Number880.5240
Classification Product Code
FPX  
Date Received07/28/1989
Decision Date 01/31/1990
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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