SUTURE FIXATION DEVICE; MESH FIXATION DEVICE


Device Classification Name

suture, nonabsorbable, synthetic, polypropylene

510(k) Number K021834
Device Name SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
Original Applicant
MLE, INC.
10 greenlawn ave.
s. grafton, 
MA 
01560

Original Contact christine e nichols
Regulation Number 878.5010
Classification Product Code
GAW  
Date Received 06/04/2002
Decision Date 08/28/2002
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