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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K183489
Device Name D2P
3D Systems, Inc.
Corner of Golan and Hanegev Street
Airport City,  IL 70151
Applicant Contact Kim Torluemke
3D Systems, Inc.
5381 South Alkire Circle
Littleton,  CO  80127
Correspondent Contact Kim Torluemke
Regulation Number892.2050
Classification Product Code
Date Received12/17/2018
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No