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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 K123329
Device Name DA VINVI SURGICAL SYSTEM
Applicant
INTUITIVE SURGICAL, INC.
1450 Kifer Rd
--
Sunnyvale,  CA  94086
Applicant Contact CINDY DOMECUS
Correspondent
INTUITIVE SURGICAL, INC.
1450 Kifer Rd
--
Sunnyvale,  CA  94086
Correspondent Contact CINDY DOMECUS
Regulation Number876.1500
Classification Product Code
NAY  
Date Received10/26/2012
Decision Date 09/17/2014
Decision SE - With Limitations (SESU)
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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