MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE


Device Classification Name

suture, surgical, absorbable, polydioxanone

510(k) Number K030212
Device Name MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
Original Applicant
GENZYME BIOSURGERY
600 airport rd.
fall river, 
MA 
02720 -4740

Original Contact steve page
Regulation Number 878.4840
Classification Product Code
NEW  
Date Received 01/21/2003
Decision Date 03/27/2003
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

Recalls CDRH Recalls