FDA 510(k) Application Details - K123463

Device Classification Name System,Surgical,Computer Controlled Instrument

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510(K) Number K123463
Device Name System,Surgical,Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BLDG. 101
SUNNYVALE, CA 94086-5206 US
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Contact CRYSTAL ONG
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Regulation Number 876.1500

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Classification Product Code NAY
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Date Received 11/09/2012
Decision Date 12/03/2012
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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