FDA 510(k) Application Details - K013052

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K013052
Device Name Camera, Multi Format, Radiological
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-CHO
HACHIOJI-SHI TOKYO 192-8505 JP
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Contact KOJIICHI KUBO
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 09/11/2001
Decision Date 01/16/2002
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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