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FDA 510(k) Application Details - K124031
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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