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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 K042811
Device Name VIVOSORB SHEET, MODEL FS01
Applicant
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Applicant Contact JAN NIEUWENHUIS
Correspondent
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Correspondent Contact JAN NIEUWENHUIS
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/12/2004
Decision Date 11/08/2004
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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