SAPH-LOOP LIGATING LOOP


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K022410
Device Name SAPH-LOOP LIGATING LOOP
Original Applicant
GENZYME BIOSURGERY
600 airport rd.
fall river, 
MA 
02720 -4740

Original Contact karen k sylvia
Regulation Number 878.5000
Classification Product Code
GAT  
Date Received 07/24/2002
Decision Date 08/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No