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510(k) K012941

DRYSTAR, MODEL 4500M by Agfa Corp. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2001
Date Received
August 31, 2001
Clearance Type
Traditional
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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