BIOKNOTLESS ANCHOR


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K002639
Device Name BIOKNOTLESS ANCHOR
Original Applicant
MITEK PRODUCTS
249 vanderbilt ave.
norwood, 
MA 
02062

Original Contact mary p legraw
Regulation Number 878.4493
Classification Product Code
GAM  
Subsequent Product Code
MAI  
Date Received 08/24/2000
Decision Date 05/11/2001
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