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510(k) K221230

TRON by Xoran Technologies, LLC — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
April 29, 2022
Clearance Type
Traditional
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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