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FDA 510(k) Application Details - K190729
Device Classification Name
More FDA Info for this Device
510(K) Number
K190729
Device Name
SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies ULC. (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby V5A 4W2 CA
Other 510(k) Applications for this Company
Contact
Agatha Szeliga
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
03/21/2019
Decision Date
04/19/2019
Decision
SESD - SUBST EQUIV - WITH DRUG
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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