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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 K002432
Device Name STRATO X
Applicant
Villa Sistemi Medicali S.P.A.
11550 W. King St.
Franklin Park,  IL  60131
Applicant Contact JEFF MOELLER
Correspondent
Villa Sistemi Medicali S.P.A.
11550 W. King St.
Franklin Park,  IL  60131
Correspondent Contact JEFF MOELLER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/08/2000
Decision Date 09/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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