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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
Device Name INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Applicant Contact CHERECE L JONES
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Correspondent Contact CHERECE L JONES
Regulation Number876.1500
Classification Product Code
NAY  
Date Received07/02/2012
Decision Date 10/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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