FDA 510(k) Application Details - K050190

Device Classification Name Table, Radiologic

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510(K) Number K050190
Device Name Table, Radiologic
Applicant VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK, IL 60131 US
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Contact VERONICA MEREDITH
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Regulation Number 892.1980

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Classification Product Code KXJ
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Date Received 01/27/2005
Decision Date 03/25/2005
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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