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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, absorbable, abdominal hernia
510(k) Number K101287
Device Name TEPHAFLEX COMPOSITE MESH
Applicant
TEPHA, INC.
99 HAYDEN AVENUE,
SUITE 360
LEXINGTON,  MA  02421
Applicant Contact MARY P LEGRAW
Correspondent
TEPHA, INC.
99 HAYDEN AVENUE,
SUITE 360
LEXINGTON,  MA  02421
Correspondent Contact MARY P LEGRAW
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
OOD   OTO   OXL  
Date Received05/07/2010
Decision Date 08/30/2010
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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