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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 K090858
Device Name PARIETEX MONOFILAMENT POLYESTER MESH
Applicant
SOFRADIM PRODUCTION
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact ANGELA BUNN
Correspondent
SOFRADIM PRODUCTION
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact ANGELA BUNN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/30/2009
Decision Date 05/06/2009
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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