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510(k) K073130

SPY FLUORESCENT IMAGING SYSTEM by Novadaq Technologies, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2008
Date Received
November 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K071619 — SPY FLUORESCENT IMAGING SYSTEM (November 9, 2007)
  • K072222 — SPY FLUORESCENT IMAGING SYSTEM (September 7, 2007)

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