FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)


Device Classification Name

instrument, biopsy

510(k) Number K103359
Device Name FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
Applicant
C.R. BARD, INC.
1415 w 3rd street
tempe, 
AZ 
85281

Applicant Contact cindy moss
Correspondent
C.R. BARD, INC.
1415 w 3rd street
tempe, 
AZ 
85281

Correspodent Contact cindy moss
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 11/16/2010
Decision Date 12/27/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No