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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 K101519
Device Name PARIETEX PLUG AND 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  
Date Received06/02/2010
Decision Date 11/05/2010
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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