FDA 510(k) Application Details - K081637

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K081637
Device Name Camera, Multi Format, Radiological
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK, NY 10017 US
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Contact RUSSELL MUNVES
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 06/11/2008
Decision Date 07/01/2008
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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