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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 K813124
Device Name ETHICON* SKIN CLOSURE TAPE
Applicant
ETHICON, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
ETHICON, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5240
Classification Product Code
KGX  
Date Received11/04/1981
Decision Date 12/08/1981
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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