TENO FIX


Device Classification Name

suture, nonabsorbable, steel, monofilament and multifilament, sterile

510(k) Number K023594
Device Name TENO FIX
Original Applicant
ORTHEON MEDICAL, LLC.
555 thirteenth st. nw
washington, 
DC 
20004 -1109

Original Contact jonathan s kahan
Regulation Number 878.4495
Classification Product Code
GAQ  
Date Received 10/25/2002
Decision Date 05/15/2003
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