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510(k) K161019

Uroview FD by Pausch Medical GmbH — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2016
Date Received
April 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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