ENCOR ENSPIRE BREAST BIOPSY SYSTEM


Device Classification Name

instrument, biopsy

510(k) Number K111100
Device Name ENCOR ENSPIRE BREAST BIOPSY SYSTEM
Applicant
C.R. BARD, INC.
1415 west 3rd st.
tempe, 
AZ 
85281 -1740

Applicant Contact justin lovelace
Correspondent
C.R. BARD, INC.
1415 west 3rd st.
tempe, 
AZ 
85281 -1740

Correspodent Contact justin lovelace
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 04/20/2011
Decision Date 06/16/2011
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