FDA 510(k) Application Details - K124031

Device Classification Name

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510(K) Number K124031
Device Name DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
Applicant INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE, CA 94086-5206 US
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Contact CINDY DOMECUS
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Regulation Number

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Classification Product Code OWN
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Date Received 12/28/2012
Decision Date 09/13/2013
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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