FDA 510(k) Application Details - K970154

Device Classification Name Film, Radiographic

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510(K) Number K970154
Device Name Film, Radiographic
Applicant EASTMAN KODAK COMPANY
1669 LAKE AVE.
ROCHESTER, NY 14652 US
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Contact MARIA DURKIN
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Regulation Number 892.1840

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Classification Product Code IWZ
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Date Received 01/16/1997
Decision Date 04/04/1997
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

FDA Source Information for K970154


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