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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, x-ray, extraoral with timer
510(k) Number K090749
Device Name ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
Applicant
VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO,  IT 20090
Applicant Contact PAOLO C SANTIN
Correspondent
VILLA SISTEMI MEDICALI S.P.A.
VIA DELLE AZALEE 3
BUCCINASCO,  IT 20090
Correspondent Contact PAOLO C SANTIN
Regulation Number872.1800
Classification Product Code
EHD  
Subsequent Product Code
MUH  
Date Received03/20/2009
Decision Date 05/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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