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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K990209
Device Name NOVAC7
Applicant
Hitesys S.P.A.
1592 Harbor Rd.
Williamsburg,  VA  23185
Applicant Contact WALTER E GUNDAKER
Correspondent
Hitesys S.P.A.
1592 Harbor Rd.
Williamsburg,  VA  23185
Correspondent Contact WALTER E GUNDAKER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/21/1999
Decision Date 06/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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