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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name film, radiographic
510(k) Number K792448
Device Name KODAK X-OMAT G FILM
Original Applicant
EASTMAN KODAK COMPANY
Regulation Number892.1840
Classification Product Code
IWZ  
Date Received11/30/1979
Decision Date 01/09/1980
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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