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510(k) K970154

KODAK EKTASIAN HG FILM (EHG-15) by Eastman Kodak Company — Product Code IWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1997
Date Received
January 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

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