FDA 510(k) Application Details - K133730

Device Classification Name System, Image Processing, Radiological

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510(K) Number K133730
Device Name System, Image Processing, Radiological
Applicant KONICA MINOLTA INC.
140 EAST 45TH ST., 25TH FL
TWO GRAND TOWER
NEW YORK, NY 10017 US
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Contact RUSSELL MUNVES
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/06/2013
Decision Date 01/31/2014
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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