BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K992088
Device Name BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 airport rd.
fall river, 
MA 
02720 -4740
Applicant Contact mary e gray
Correspondent
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 airport rd.
fall river, 
MA 
02720 -4740
Correspodent Contact mary e gray
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 06/21/1999
Decision Date 09/03/1999
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