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510(k) K071037

SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 by Novadaq Technologies, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2007
Date Received
April 12, 2007
Clearance Type
Special
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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