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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgical film
510(k) Number K070894
Device Name TEPHAFLEX SURGICAL MESH
Original Applicant
TEPHA, INC.
840 memorial drive
3rd floor
cambridge,  MA  02139
Original Contact mary p legraw
Regulation Number878.3300
Classification Product Code
OOD  
Subsequent Product Code
OTO  
Date Received03/30/2007
Decision Date 04/13/2007
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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