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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name confocal optical imaging
510(k) Number K124031
Device Name DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Applicant Contact CINDY DOMECUS
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE,  CA  94086 -5206
Correspondent Contact CINDY DOMECUS
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/28/2012
Decision Date 09/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01410734
Reviewed by Third Party No
Combination Product Yes
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