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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, angiographic
510(k) Number K071619
Device Name SPY FLUORESCENT IMAGING SYSTEM
Applicant
NOVADAQ TECHNOLOGIES, INC.
2585 SKYMARK AVENUE, STE. 306
MISSISSAUGA, ONTARIO,  CA L4W 4L5
Applicant Contact ALLISON MANNERS
Correspondent
NOVADAQ TECHNOLOGIES, INC.
2585 SKYMARK AVENUE, STE. 306
MISSISSAUGA, ONTARIO,  CA L4W 4L5
Correspondent Contact ALLISON MANNERS
Regulation Number892.1600
Classification Product Code
IZI  
Date Received06/13/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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