SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)


information about

Device Classification Name

suture, nonabsorbable, synthetic, polypropylene

510(k) Number K002557
Device Name SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
Original Applicant
AXYA MEDICAL, INC.
100 cummings center
suite 444c
beverly, 
MA 
01915

Original Contact howard l schrayer
Regulation Number 878.5010
Classification Product Code
GAW  
Date Received 08/17/2000
Decision Date 10/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No