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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K914871
Device Name TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact LORA L JONES
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact LORA L JONES
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/29/1991
Decision Date 12/18/1991
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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