ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K072863
Device Name ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
Applicant
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact allan p schwartz
Correspondent
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact allan p schwartz
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 10/05/2007
Decision Date 05/23/2008
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