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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 K110815
Device Name PARIETEX OPTIMIZED COMPOSTIE MESH
Applicant
SOFRADIM PRODUCTION
BIOSURGERY
15 CROSBY DRIVE
BEDFORD,  MA  01730
Applicant Contact JAMES MCMAHON
Correspondent
SOFRADIM PRODUCTION
BIOSURGERY
15 CROSBY DRIVE
BEDFORD,  MA  01730
Correspondent Contact JAMES MCMAHON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/24/2011
Decision Date 04/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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