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510(k) K162619

I View and Imagen Sensor by Trident S.R.L — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
September 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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