FDA 510(k) Application Details - K060867

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K060867
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
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 03/30/2006
Decision Date 05/03/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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