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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 K872250
Device Name LECTEC STIMULATING ELECTRODE
Applicant
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Applicant Contact DAVID MONTECALVO
Correspondent
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Correspondent Contact DAVID MONTECALVO
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/12/1987
Decision Date 08/07/1987
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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