TEPHAFLEX ABSORBABLE SUTURE


Device Classification Name

suture, recombinant technology

510(k) Number K081099
Device Name TEPHAFLEX ABSORBABLE SUTURE
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 Number 878.4494
Classification Product Code
NWJ  
Date Received 04/17/2008
Decision Date 07/15/2008
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