FDA 510(k) Application Details - K963913

Device Classification Name Screen, Intensifying, Radiographic

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510(K) Number K963913
Device Name Screen, Intensifying, Radiographic
Applicant KONICA MEDICAL 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 892.1960

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Classification Product Code EAM
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Date Received 09/30/1996
Decision Date 10/08/1997
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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