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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 K143457
Device Name NeuroBlate System
Applicant
MONTERIS MEDICAL, INC.
16305 36th Ave. North Suite 200
Plymouth,  MN  55446
Applicant Contact Brooke Ren
Correspondent
COOMBS MEDICAL DEVICE CONSULTING
1193 SHERMAN STREET
ALAMEDA,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HAW  
Date Received12/03/2014
Decision Date 02/19/2015
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
Recalls CDRH Recalls
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