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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 K002672
Device Name VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
Applicant
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact KAREN LESSIG
Correspondent
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Correspondent Contact KAREN LESSIG
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/28/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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