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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, extraoral source, digital
510(k) Number K111152
Device Name ROTOGRAPH EVO 3D
Applicant
VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO,  IT 20090
Applicant Contact PAOLO CASAGRANDE SANTIN
Correspondent
VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO,  IT 20090
Correspondent Contact PAOLO CASAGRANDE SANTIN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/25/2011
Decision Date 07/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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