NON-BIOABSORBABLE STAPLE


Device Classification Name

suture, nonabsorbable, nitinol

510(k) Number K023372
Device Name NON-BIOABSORBABLE STAPLE
Original Applicant
ONUX MEDICAL, INC.
5 merrill dr.
hampton, 
NH 
03842

Original Contact ruthann depietro
Regulation Number 878.4495
Classification Product Code
NJU  
Subsequent Product Code
GCJ  
Date Received 10/08/2002
Decision Date 12/27/2002
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