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510(k) K052251

DRYSTAR MODEL 5500 by Agfa Corporation — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2005
Date Received
August 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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