FDA 510(k) Application Details - K971894

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K971894
Device Name Digitizer, Image, Radiological
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650-1131 US
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Contact JUDITH A WALLACE
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 05/22/1997
Decision Date 08/20/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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