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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 K181859
Device Name Visualase Thermal Therapy System
Applicant
Medtronic Navigation Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Rishi Sinha
Correspondent
Medtronic Navigation Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Sharon L. McDermott
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
FRN   GEX  
Date Received07/12/2018
Decision Date 03/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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