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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 K881114
Device Name EMPI MODEL 989, TENS
Applicant
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Applicant Contact E MATHIESEN
Correspondent
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Correspondent Contact E MATHIESEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/15/1988
Decision Date 04/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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