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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiologic
510(k) Number K050190
Device Name APOLLO
Applicant
VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK,  IL  60131
Applicant Contact VERONICA MEREDITH
Correspondent
VILLA SISTEMI MEDICALI S.P.A.
11550 WEST KING ST.
FRANKLIN PARK,  IL  60131
Correspondent Contact VERONICA MEREDITH
Regulation Number892.1980
Classification Product Code
KXJ  
Subsequent Product Codes
IXL   KPW  
Date Received01/27/2005
Decision Date 03/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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