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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 K141983
Device Name NEUROBLATE SYSTEM
Applicant
MONTERIS MEDICAL CORP
1193 SHERMAN STREET
ALAMEDA,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
MONTERIS MEDICAL CORP
1193 SHERMAN STREET
ALAMEDA,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HAW  
Date Received07/21/2014
Decision Date 08/11/2014
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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