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510(k) K152162

Myray- HYPERION X5 by Cefla S.C. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2015
Date Received
August 3, 2015
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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