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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K210347
Device Name VSP System
Applicant
3D Systems
5381 S Alkire Circle
Littleton,  CO  80127
Applicant Contact Scott Brewer
Correspondent
3D Systems
5381 S Alkire Circle
Littleton,  CO  80127
Correspondent Contact Scott Brewer
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received02/08/2021
Decision Date 04/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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