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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K190044
Device Name VSP Orthopedics System
Applicant
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Applicant Contact Kim Torluemke
Correspondent
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Correspondent Contact Kim Torluemke
Regulation Number888.3030
Classification Product Code
PBF  
Date Received01/09/2019
Decision Date 08/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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