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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 K173305
Device Name NeuroBlate System
Applicant
Monteris Medical,
14755 27th Ave. N
Suite C
Plymouth,  MN  55447
Applicant Contact David H. Mueller
Correspondent
Monteris Medical,
14755 27th Ave. N
Suite C
Plymouth,  MN  55447
Correspondent Contact David H. Mueller
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HAW  
Date Received10/18/2017
Decision Date 11/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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