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510(k) K013686

KODAK DIRECTVIEW TABLETOP CASSETTE by Eastman Kodak Company — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2001
Date Received
November 7, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

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