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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, radiographic, tilting
510(k) Number K000412
Device Name VISION R/F TILTING TABLE
Applicant
VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK,  IL  60131
Applicant Contact JEFFERY N MOELLER
Correspondent
VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK,  IL  60131
Correspondent Contact JEFFERY N MOELLER
Regulation Number892.1980
Classification Product Code
IXR  
Subsequent Product Code
JAA  
Date Received02/08/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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