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510(k) K093683

ORTHOPANTOMOGRAPH OP300 by Instrumentarium Dental, Palodex Group OY — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2010
Date Received
November 30, 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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