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510(k) K042961

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2005
Date Received
October 27, 2004
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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