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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 K211966
Device Name Segment 3DPrint
Applicant
Medviso Ab
Griffelvägen 3
Lund,  SE SE-22467
Applicant Contact Einar Heiberg
Correspondent
Medviso Ab
Griffelvägen 3
Lund,  SE SE-22467
Correspondent Contact Einar Heiberg
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/24/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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