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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 K033376
Device Name UGYTEX MESH
Applicant
Sofradim Production
5 Whitcomb Ave.
Ayer,  MA  01432
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Sofradim Production
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/22/2003
Decision Date 01/15/2004
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
Predetermined Change
Control Plan Authorized		 No
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