MANUAL TOUCHE SYSTEM


Device Classification Name

suture, nonabsorbable, steel, monofilament and multifilament, sterile

510(k) Number K022777
Device Name MANUAL TOUCHE SYSTEM
Original Applicant
ONUX MEDICAL, INC.
5 merrill dr.
hampton, 
NH 
03842

Original Contact ruthann depietro
Regulation Number 878.4495
Classification Product Code
GAQ  
Subsequent Product Code
HCF  
Date Received 08/21/2002
Decision Date 11/19/2002
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