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FDA 510(k) Application Details - K112584
Device Classification Name
System,Surgical,Computer Controlled Instrument
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510(K) Number
K112584
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE, CA 94086-5206 US
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Contact
KIM T SERVANCE
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Regulation Number
876.1500
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Classification Product Code
NAY
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More FDA Info for this Product Code
Date Received
09/06/2011
Decision Date
09/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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