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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 K131969
Device Name SYMBOTEX(TM) COMPOSITE MESH
Applicant
SOFRADIM PRODUCTION
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact CLARE SANTULLI
Correspondent
SOFRADIM PRODUCTION
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact CLARE SANTULLI
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received06/28/2013
Decision Date 08/22/2013
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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