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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number876.1075
Classification Product Code
KNW  
Date Received05/23/2002
Decision Date 08/14/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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