MAMMOTOME ELITE BIOPSY SYSTEM


Device Classification Name

instrument, biopsy

510(k) Number K112411
Device Name MAMMOTOME ELITE BIOPSY SYSTEM
Applicant
DEVICOR MEDICAL PRODUCTS INC.
300 e. business way
fifth floor
cincinnati, 
OH 
45241 -0000

Applicant Contact shawna m rose
Correspondent
DEVICOR MEDICAL PRODUCTS INC.
300 e. business way
fifth floor
cincinnati, 
OH 
45241 -0000

Correspodent Contact shawna m rose
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 08/22/2011
Decision Date 03/20/2012
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