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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,surgical,computer controlled instrument
510(k) Number K122532
Device Name DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
Original Applicant
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale,  CA  94086 5206
Original Contact melissa s gonzalez
Regulation Number876.1500
Classification Product Code
NAY  
Date Received08/20/2012
Decision Date 07/30/2013
Decision substantially equivalent - with limitations (SU)
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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