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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K222639
Device Name VHA Radiotherapy Bolus
Applicant
Vha Dean
810 Vermont Ave., NW
Washington,  DC  20420
Applicant Contact Beth Ripley
Correspondent
Lg Strategies, LLC
3903 S. Congress Ave., #3930
Austin,  TX  78704
Correspondent Contact Laura Gilmour
Regulation Number892.5710
Classification Product Code
IXI  
Date Received09/01/2022
Decision Date 11/04/2022
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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