FDA 510(k) Application Details - K000412

Device Classification Name Table, Radiographic, Tilting

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510(K) Number K000412
Device Name Table, Radiographic, Tilting
Applicant VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK, IL 60131 US
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Contact JEFFERY N MOELLER
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Regulation Number 892.1980

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Classification Product Code IXR
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Date Received 02/08/2000
Decision Date 04/24/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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