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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 K880649
Device Name TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
Applicant
LABELTAPE MEDITECT, INC.
4275 AIRWEST DR., S.E.
P.O. BOX 8823
GRAND RAPIDS,  MI  49508
Applicant Contact MICHAEL S BARTLETT
Correspondent
LABELTAPE MEDITECT, INC.
4275 AIRWEST DR., S.E.
P.O. BOX 8823
GRAND RAPIDS,  MI  49508
Correspondent Contact MICHAEL S BARTLETT
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/17/1988
Decision Date 03/04/1988
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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