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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
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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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