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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K863136
Device Name HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
Applicant
Neurotechnics, Inc.
P.O. Box 6367
Annapolis,  MD  21401
Applicant Contact THOMAS FURLOW
Correspondent
Neurotechnics, Inc.
P.O. Box 6367
Annapolis,  MD  21401
Correspondent Contact THOMAS FURLOW
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received08/15/1986
Decision Date 09/04/1987
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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