FDA 510(k) Application Details - K992586

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K992586
Device Name Camera, Multi Format, Radiological
Applicant KONICA CORP.
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN 5190501 JP
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Contact KAY HAMAGUCHI
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 08/02/1999
Decision Date 10/29/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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