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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 K022574
Device Name INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
Applicant
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086 -5206
Applicant Contact USHA S KREADEN
Correspondent
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086 -5206
Correspondent Contact USHA S KREADEN
Regulation Number876.1500
Classification Product Code
NAY  
Date Received08/02/2002
Decision Date 11/12/2002
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
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