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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 K890604
Device Name EMPI, MODEL 489, TENS
Applicant
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Applicant Contact STACY MATTSON
Correspondent
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Correspondent Contact STACY MATTSON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/06/1989
Decision Date 06/01/1989
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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