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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K231061
Device Name NeuroBlate System
Applicant
Monteris Medical,
131 Cheshire Lane
Suite 100
Minnetonka,  MN  55305
Applicant Contact David H Mueller
Correspondent
Monteris Medical,
131 Cheshire Lane
Suite 100
Minnetonka,  MN  55305
Correspondent Contact David H Mueller
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
HAW   ONO  
Date Received04/13/2023
Decision Date 12/08/2023
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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