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510(k) K032635

DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 by Agfa Corp. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2003
Date Received
August 26, 2003
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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