SOFT TISSUE ANCHORING WASHERS


Device Classification Name

retention device, suture

510(k) Number K030031
Device Name SOFT TISSUE ANCHORING WASHERS
Original Applicant
ACCU-SPEED, INCORPORATED
p.o. box 1008, 65 gay rd.
groton, 
MA 
01450

Original Contact robert w secovich
Regulation Number 878.4930
Classification Product Code
KGS  
Subsequent Product Code
MBI  
Date Received 01/03/2003
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No