SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS


Device Classification Name

instrument, biopsy

510(k) Number K021707
Device Name SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
Original Applicant
SENORX, INC.
11 columbia, suite a
aliso viejo, 
CA 
92656

Original Contact amy boucly
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 05/23/2002
Decision Date 08/14/2002
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