FDA 510(k) Application Details - K983905

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K983905
Device Name Camera, Multi Format, Radiological
Applicant EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER, NY 14653-0002 US
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Contact JUDITH A WALLACE
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 11/03/1998
Decision Date 01/25/1999
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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