PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.


Device Classification Name

suture, surgical, absorbable, polydioxanone

510(k) Number K022666
Device Name PDO (POLYDIOXANONE) MONOFILAMENT 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 878.4840
Classification Product Code
NEW  
Date Received 08/09/2002
Decision Date 10/09/2002
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