BONE BIOPSY NEEDLE


Device Classification Name

instrument, biopsy

510(k) Number K001132
Device Name BONE BIOPSY NEEDLE
Original Applicant
PROMEX, INC.
3049 hudson st.
franklin, 
IN 
46131

Original Contact joseph l mark
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 04/10/2000
Decision Date 05/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No