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FDA 510(k) Application Details - K071037
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K071037
Device Name
System, X-Ray, Angiographic
Applicant
NOVADAQ TECHNOLOGIES, INC.
2585 SKYMARK AVENUE, STE. 306
MISSISSAUGA, ONTARIO L4W 4L5 CA
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Contact
ALLISON MANNERS
Other 510(k) Applications for this Contact
Regulation Number
892.1600
More FDA Info for this Regulation Number
Classification Product Code
IZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/12/2007
Decision Date
05/10/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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