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510(k) K171534

SurgicalPreview by Endo Vantage, LLC — Product Code PZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2017
Date Received
May 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class
Class II
Regulation Number
892.2050
Review Panel
CV
Submission Type

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.

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