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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 K072520
Device Name TEPHAFLEX SURGICAL FILM
Applicant
TEPHA, INC.
99 HAYDEN, SUTIE 360
LEXINGTON,  MA  02421
Applicant Contact MARY LEGRAW
Correspondent
TEPHA, INC.
99 HAYDEN, SUTIE 360
LEXINGTON,  MA  02421
Correspondent Contact MARY LEGRAW
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
NWJ  
Date Received09/07/2007
Decision Date 11/29/2007
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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