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510(k) K092591

ORTHOPANTOMOGRAPH OP30 by Instrumentarium Dental, Palodex Group OY — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2009
Date Received
August 24, 2009
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

Other clearances by Instrumentarium Dental, Palodex Group OY

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  • K063837 — SIGMA M (July 2, 2007)

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