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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K200907
Device Name Thales 3D Mr Scanner
Applicant
Lap GmbH Laser Applikationen
Zeppelinstrasse 23
Lueneburg,  DE 21335
Applicant Contact Martin Pfabel
Correspondent
Lap GmbH Laser Applikationen
Zeppelinstrasse 23
Lueneburg,  DE 21335
Correspondent Contact Martin Pfabel
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/06/2020
Decision Date 06/03/2020
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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