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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 K140941
Device Name PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
Applicant
SOFRADIM PRODUCTION
60 MIDDLETON AVE
NORTH HAVEN,  CT  06473
Applicant Contact CLARE SANTULLI
Correspondent
SOFRADIM PRODUCTION
60 MIDDLETON AVE
NORTH HAVEN,  CT  06473
Correspondent Contact CLARE SANTULLI
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/14/2014
Decision Date 05/07/2014
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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