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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
Original Applicant
TEPHA, INC.
99 hayden avenue,
suite 360
lexington,  MA  02421
Original 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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