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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 K093217
Device Name 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
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 Received10/13/2009
Decision Date 01/21/2010
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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