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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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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