SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012


Device Classification Name

instrument, biopsy

510(k) Number K080171
Device Name SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
Applicant
SANARUS MEDICAL, INC.
4696 willow rd.
pleasanton, 
CA 
94588

Applicant Contact lisa henry
Correspondent
SANARUS MEDICAL, INC.
4696 willow rd.
pleasanton, 
CA 
94588

Correspodent Contact lisa henry
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 01/24/2008
Decision Date 03/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No