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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 K063220
Device Name DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Applicant Contact MICHAEL H YRAMATEGUI
Correspondent
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Correspondent Contact MICHAEL H YRAMATEGUI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received10/24/2006
Decision Date 12/01/2006
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
Recalls CDRH Recalls
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