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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 K861830
Device Name EMPI MODEL GLS 450, TENS
Applicant
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Applicant Contact GEORGE E MATHIESEN
Correspondent
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Correspondent Contact GEORGE E MATHIESEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/13/1986
Decision Date 07/15/1986
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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