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FDA 510(k) Application Details - K162885
Device Classification Name
More FDA Info for this Device
510(K) Number
K162885
Device Name
SPY Phi Open Field Handheld Fluorescence Imaging System
Applicant
NOVADAQ TECHNOLOGIES INC.
8329 EASTLAKE DRIVE
UNIT 101
Burnaby V5A 4W2 CA
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Contact
JEN PENDLEBURY
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
10/17/2016
Decision Date
01/11/2017
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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