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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 K120440
Model HD0001
Device Name PRESTO BREAST BIOPSY DEVICE
Original Applicant
SONTINA MEDICAL, LLC
111 sutro heights avenue
san francisco,  CA  94121
Original Contact robert peliks
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/13/2012
Decision Date 05/17/2012
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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