AUTOMATED CORE BIOPSY DEVICE


Device Classification Name

biopsy needle kit

510(k) Number K011270
Device Name AUTOMATED CORE BIOPSY DEVICE
Original Applicant
PROMEX, INC.
3049 hudson st.
franklin, 
IN 
46131

Original Contact joseph l mark
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 04/26/2001
Decision Date 06/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No