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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 K214093
Device Name VSP Bolus
Applicant
3D Systems
5381 S Alkire Circle
Littleton,  CO  80127
Applicant Contact Benjamin Johnson
Correspondent
3D Systems
5381 S Alkire Circle
Littleton,  CO  80127
Correspondent Contact Benjamin Johnson
Regulation Number892.5710
Classification Product Code
IXI  
Date Received12/28/2021
Decision Date 03/30/2022
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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