FDA 510(k) Application Details - K111152

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K111152
Device Name System,X-Ray,Extraoral Source,Digital
Applicant VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO 20090 IT
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Contact PAOLO CASAGRANDE SANTIN
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 04/25/2011
Decision Date 07/22/2011
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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