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FDA 510(k) Application Details - K974597
Device Classification Name
System, X-Ray, Stationary
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510(K) Number
K974597
Device Name
System, X-Ray, Stationary
Applicant
BAYER CORP., AGFA DIV.
100 CHALLENGER RD.
RIDGEFIELD PARK, NJ 07660 US
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Contact
MICHAEL SULLIVAN
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Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
12/09/1997
Decision Date
03/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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