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510(k) K032550

EXOMIO, MODEL 2.0 SP1 by Medcom GmbH — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2003
Date Received
August 18, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

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