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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 K080291
Device Name INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
Applicant
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086 -5206
Applicant Contact KAREN UYESUGI
Correspondent
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086 -5206
Correspondent Contact KAREN UYESUGI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received02/04/2008
Decision Date 03/19/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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