ARTHREX FIBERWIRE IN USP SIZES


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K021434
Device Name ARTHREX FIBERWIRE IN USP SIZES
Original Applicant
ARTHREX, INC.
2885 south horseshoe dr.
naples, 
FL 
34104

Original Contact ann waterhouse
Regulation Number 878.5000
Classification Product Code
GAT  
Date Received 05/06/2002
Decision Date 11/07/2002
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