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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K852462
Device Name TRICOT ADHESIVE BANDAGE
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
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/10/1985
Decision Date 07/26/1985
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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