FDA 510(k) Application Details - K000159

Device Classification Name System, Imaging, X-Ray, Electrostatic

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510(K) Number K000159
Device Name System, Imaging, X-Ray, Electrostatic
Applicant AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact TIMOTHY W CAPEHART
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Regulation Number 892.1630

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Classification Product Code IXK
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Date Received 01/19/2000
Decision Date 02/16/2000
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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