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FDA 510(k) Application Details - K990969
Device Classification Name
Processor, Radiographic-Film, Automatic
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510(K) Number
K990969
Device Name
Processor, Radiographic-Film, Automatic
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
892.1900
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Classification Product Code
IXW
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More FDA Info for this Product Code
Date Received
03/23/1999
Decision Date
06/18/1999
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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