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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 K260976
Device Name NeuroBlate System
Applicant
Monteris Medical
131 Cheshire Ln.
Suite 100
Minnetonka,  MN  55305
Applicant Contact David Mueller
Correspondent
Monteris Medical
131 Cheshire Ln.
Suite 100
Minnetonka,  MN  55305
Correspondent Contact David Mueller
Regulation Number878.4810
Classification Product Code
ONO  
Subsequent Product Codes
GEX   HAW  
Date Received03/24/2026
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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