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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 K040998
Device Name MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
Applicant
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact MARY MCNAMARA-CULLINANE, RAC
Correspondent
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact MARY MCNAMARA-CULLINANE, RAC
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/19/2004
Decision Date 04/29/2004
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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