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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 K882631
Device Name EMPI MODEL 727,NMS
Applicant
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Applicant Contact GEORGE E MATHIESEN
Correspondent
EMPI
1275 GREY FOX RD.
ST PAUL,  MN  55112
Correspondent Contact GEORGE E MATHIESEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/27/1988
Decision Date 09/22/1988
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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