FDA 510(k) Application Details - K020635

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K020635
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650 US
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Contact SUSAN PATE
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 02/27/2002
Decision Date 03/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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