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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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More FDA Info for this Product Code
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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