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FDA 510(k) Application Details - K042779
Device Classification Name
System, Imaging, X-Ray, Electrostatic
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510(K) Number
K042779
Device Name
System, Imaging, X-Ray, Electrostatic
Applicant
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact
JEFFERY A JEDLICKA
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Regulation Number
892.1630
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Classification Product Code
IXK
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More FDA Info for this Product Code
Date Received
10/06/2004
Decision Date
10/21/2004
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
Y
Expedited Review
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