FDA 510(k) Application Details - K061999

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K061999
Device Name Camera, Multi Format, Radiological
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-MACHI
HACHIOJI-SHI, TOKYO 192-8505 JP
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Contact JOJI MATSUSHIMA
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 07/14/2006
Decision Date 08/15/2006
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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