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510(k) K151904

SyncVision System by Volcano Corporation — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2015
Date Received
July 13, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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