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FDA 510(k) Application Details - K042159
Device Classification Name
Camera, Multi Format, Radiological
More FDA Info for this Device
510(K) Number
K042159
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
Other 510(k) Applications for this Contact
Regulation Number
892.2040
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Classification Product Code
LMC
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More FDA Info for this Product Code
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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