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510(k) K040378

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 by Eastman Kodak Company — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2004
Date Received
February 17, 2004
Clearance Type
Traditional
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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