FDA 510(k) Application Details - K023801

Device Classification Name Processor, Radiographic-Film, Automatic

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510(K) Number K023801
Device Name Processor, Radiographic-Film, Automatic
Applicant S.A.I.E.P. S.R.L.
2740-EAST FRONTAGE RD.
WEATHERFORD, OK 73096-3658 US
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Contact DOUG HALE
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Regulation Number 892.1900

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Classification Product Code IXW
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Date Received 11/14/2002
Decision Date 02/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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