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510(k) K021829

MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM by Eastman Kodak Company — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
June 4, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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