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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 K120506
Device Name PARIETEX COMPOSITE VENTRAL PATCH
Applicant
SOFRADIM PRODUCTION
15 CROSBY DR
BEDFORD,  MA  01730
Applicant Contact JAMES MCMAHON
Correspondent
SOFRADIM PRODUCTION
15 CROSBY DR
BEDFORD,  MA  01730
Correspondent Contact JAMES MCMAHON
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received02/21/2012
Decision Date 06/13/2012
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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