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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 K120189
Device Name BONETRAP
Original Applicant
p.o. box 139
fernandina beach,  FL  32035
Original Contact nicola berni
Regulation Number876.1075
Classification Product Code
Date Received01/23/2012
Decision Date 02/22/2012
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