PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K022664
Device Name PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
Original Applicant
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
1591 s. moorland rd.
suite 104
new berlin, 
WI 
53151

Original Contact charles f andrews
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 08/09/2002
Decision Date 09/10/2002
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