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510(k) K170385

CORE M2 Vascular System by Volcano Corporation — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2017
Date Received
February 8, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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