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FDA 510(k) Application Details - K963914
Device Classification Name
Cassette, Radiographic Film
More FDA Info for this Device
510(K) Number
K963914
Device Name
Cassette, Radiographic Film
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
892.1850
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Classification Product Code
IXA
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More FDA Info for this Product Code
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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