TEPHAFLEX MESH


Device Classification Name

surgical film

510(k) Number K111946
Device Name TEPHAFLEX MESH
Applicant
TEPHA, INC.
99 hayden avenue,
suite 360
lexington, 
MA 
02421

Applicant Contact mary p legraw
Correspondent
TEPHA, INC.
99 hayden avenue,
suite 360
lexington, 
MA 
02421

Correspodent Contact mary p legraw
Regulation Number 878.3300
Classification Product Code
OOD  
Date Received 07/08/2011
Decision Date 09/26/2011
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