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510(k) K072680

DRYSTAR AXYS, MODEL EYZ4E by Agfa Healthcare Corporation — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2007
Date Received
September 24, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

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