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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 K091633
Device Name TEPHAFLEX SURGICAL FILM
Applicant
TEPHA, INC.
99 hayden, sutie 360
lexington,  MA  02421
Applicant Contact mary p legraw
Correspondent
TEPHA, INC.
99 hayden, sutie 360
lexington,  MA  02421
Correspodent Contact mary p legraw
Regulation Number878.3300
Classification Product Code
OOD  
Subsequent Product Code
PAJ  
Date Received06/04/2009
Decision Date 08/07/2009
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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