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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 K895884
Device Name BANDAGE REMOVAL STRIP
Applicant
KUT-GUARD, INC.
P.O. BOX 6402
HOLLYWOOD,  FL  33081
Applicant Contact WIN HIRSCH
Correspondent
KUT-GUARD, INC.
P.O. BOX 6402
HOLLYWOOD,  FL  33081
Correspondent Contact WIN HIRSCH
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/05/1989
Decision Date 12/27/1989
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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