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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor
510(k) Number K801699
Device Name ETHICON RETRACTION TAPE
Applicant
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GAD  
Date Received07/23/1980
Decision Date 09/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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