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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 K991772
Device Name CUTANEOUS (DISC) ELECTRODE
Applicant
Neuro Supplies, Inc.
86 Boston Post Rd.
Waterford,  CT  06385
Applicant Contact RONALD LUICH
Correspondent
Neuro Supplies, Inc.
86 Boston Post Rd.
Waterford,  CT  06385
Correspondent Contact RONALD LUICH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/24/1999
Decision Date 08/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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