TEPHAFLEX SURGICAL FILM


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

Correspodent Contact mary legraw
Regulation Number 878.3300
Classification Product Code
FTL  
Subsequent Product Code
NWJ  
Date Received 09/07/2007
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