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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K982351
Device Name LUNA
Applicant
Stellate Systems
345 Victoria Ave., Suite 505
Westmount, Quebec,
Canada, H32 2n2,  CA
Applicant Contact GEORGE PAPAGIANNIS
Correspondent
Stellate Systems
345 Victoria Ave., Suite 505
Westmount, Quebec,
Canada, H32 2n2,  CA
Correspondent Contact GEORGE PAPAGIANNIS
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OLV  
Date Received07/06/1998
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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