FDA 510(k) Application Details - K042158

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K042158
Device Name Camera, Multi Format, Radiological
Applicant EASTMAN KODAK COMPANY
1 IMATION WAY
304-3B-61
OAKDALE, MN 55128-3414 US
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Contact STEPHEN SLAVENS
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 08/10/2004
Decision Date 09/24/2004
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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