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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 K071629
Device Name PARIETEX POLYESTER MESH WITH INTRODUCER
Applicant
SOFRADIM PRODUCTION
HEALTHCARE GROUP
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact RENEE BORGESANO
Correspondent
SOFRADIM PRODUCTION
HEALTHCARE GROUP
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact RENEE BORGESANO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/14/2007
Decision Date 07/10/2007
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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