FDA 510(k) Application Details - K970059

Device Classification Name Processor, Radiographic-Film, Automatic

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510(K) Number K970059
Device Name Processor, Radiographic-Film, Automatic
Applicant EASTMAN KODAK COMPANY
901 ELMGROVE RD.
ROCHESTER, NY 14653-0002 US
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Contact KENNETH OEMCKE
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Regulation Number 892.1900

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Classification Product Code IXW
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Date Received 01/07/1997
Decision Date 01/27/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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