SUTURTEK FASTCLOSE SUTURING DEVICE


Device Classification Name

suture, absorbable, natural

510(k) Number K030227
Device Name SUTURTEK FASTCLOSE SUTURING DEVICE
Original Applicant
SUTURTEK INCORPORATED
7 tiffany trail
hopkinton, 
MA 
01748

Original Contact debbie iampietro
Regulation Number 878.4830
Classification Product Code
GAL  
Date Received 01/22/2003
Decision Date 03/17/2003
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