FULL CORE BIOPSY SYSTEM


Device Classification Name

instrument, biopsy

510(k) Number K111765
Device Name FULL CORE BIOPSY SYSTEM
Applicant
PROMEX TECHNOLOGIES, LLC
9001 wesleyan road
indianapolis, 
IN 
46268

Applicant Contact allison scott
Correspondent
PROMEX TECHNOLOGIES, LLC
9001 wesleyan road
indianapolis, 
IN 
46268

Correspodent Contact allison scott
Regulation Number 876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received 06/23/2011
Decision Date 09/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No