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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 K131278
Device Name MONTERIS MEDICAL NEUROBLATE SYSTEM
Applicant
MONTERIS MEDICAL, INC.
1193 SHERMAN ST
ALAMEDA,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
MONTERIS MEDICAL, INC.
1193 SHERMAN ST
ALAMEDA,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HAW  
Date Received05/06/2013
Decision Date 07/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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