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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 K121921
Model IS2000 AND IS3000
Device Name INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
Original Applicant
INTUITIVE SURGICAL, INC.
1266 kifer road
building 101
sunnyvale,  CA  94086 5206
Original Contact cherece l jones
Regulation Number876.1500
Classification Product Code
NAY  
Date Received07/02/2012
Decision Date 10/25/2012
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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