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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 K123840
Device Name CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
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 Received12/13/2012
Decision Date 02/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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