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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 K863307
Device Name TENZCARE SNAP ELECTRODE, NO. 6865
Applicant
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Applicant Contact CHARLES W OPP
Correspondent
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Correspondent Contact CHARLES W OPP
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/25/1986
Decision Date 09/23/1986
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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