FDA 510(k) Application Details - K980873

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K980873
Device Name Digitizer, Image, Radiological
Applicant KONICA CORP.
THE CHRYSLER BUILDING
405 LEXINGTON AVENUE
NEW YORK, NY 10174 US
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Contact RUSSELL D MUNVES
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 03/06/1998
Decision Date 06/19/1998
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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