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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K010638
Device Name NEUROPLUS, MODEL A10040, A10041, A10042, A10043
Applicant
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Applicant Contact MARC FILLION
Correspondent
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Correspondent Contact MARC FILLION
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/05/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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