FDA 510(k) Application Details - K090749

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K090749
Device Name Unit, X-Ray, Extraoral With Timer
Applicant VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO 20090 IT
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Contact PAOLO C SANTIN
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 03/20/2009
Decision Date 05/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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