CO-AXIAL INTRODUCER NEEDLE


Device Classification Name

introducer, catheter

510(k) Number K022634
Device Name CO-AXIAL INTRODUCER NEEDLE
Original Applicant
PROMEX, INC.
3049 hudson st.
franklin, 
IN 
46131

Original Contact joseph l mark
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/08/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No