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510(k) K173646

FS Ergo by Palodex Group OY — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2017
Date Received
November 27, 2017
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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