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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
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