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FDA 510(k) Application Details - K110639
Device Classification Name
System,Surgical,Computer Controlled Instrument
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510(K) Number
K110639
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE, CA 94086 US
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Contact
BRANDON HANSEN
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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
03/04/2011
Decision Date
12/28/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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