BIOPSY SITE TISSUE MARKER DEVICE


Device Classification Name

marker, radiographic, implantable

510(k) Number K023450
Device Name BIOPSY SITE TISSUE MARKER DEVICE
Original Applicant
PROMEX, INC.
3049 hudson st.
franklin, 
IN 
46131

Original Contact joseph l mark
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 10/15/2002
Decision Date 12/19/2002
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