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510(k) K983267

DIGORA FOR WINDOWS 2.0 by Orion Corporation Soredex — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1998
Date Received
September 17, 1998
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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