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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 K153705
Device Name PROcedure Rehearsal Studio
Applicant
3Dsystems, Simbionix Products
Beit Golan Corner Of Golan And Hanegev St.
Airport City,  IL 70151
Applicant Contact KIM TORLUEMKE
Correspondent
3D Systems, Inc.
5381 S Alkire Circle
Littleton,  CO  80127
Correspondent Contact Kim Torluemke
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/23/2015
Decision Date 09/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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