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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Laser With Mr Thermography
510(k) Number K214125
Device Name TRANBERG Thermoguide Therapy System
Applicant
Clinical Laserthermia Systems, AB
Scheelevägen 2
Lund,  SE 22381
Applicant Contact Dan Mogren
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number878.4810
Classification Product Code
ONO  
Date Received12/30/2021
Decision Date 09/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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