FDA 510(k) Application Details - K060055

Device Classification Name System, Image Processing, Radiological

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510(K) Number K060055
Device Name System, Image Processing, Radiological
Applicant EASTMAN KODAK COMPANY
343 STATE STREET
ROCHESTER, NY 14650 US
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Contact CAROLYN L WAGNER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/09/2006
Decision Date 02/07/2006
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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