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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 K083307
Device Name SYNTHASOME X-REPAIR
Applicant
SYNTHASOME, INC.
3030 BUNKER HILL ST.
SUITE 308
SAN DIEGO,  CA  92109
Applicant Contact ANTHONY RATCLIFFE
Correspondent
SYNTHASOME, INC.
3030 BUNKER HILL ST.
SUITE 308
SAN DIEGO,  CA  92109
Correspondent Contact ANTHONY RATCLIFFE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/10/2008
Decision Date 03/27/2009
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
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