FDA 510(k) Application Details - K032635

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K032635
Device Name Camera, Multi Format, Radiological
Applicant AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact JEFF JEDLICKA
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 08/26/2003
Decision Date 09/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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