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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K810428
FOIA Releasable 510(k) K810428
Device Name VICRYL
Applicant
ETHICON, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
ETHICON, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/18/1981
Decision Date 03/13/1981
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
Predetermined Change
Control Plan Authorized		 No
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