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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K854774
Device Name EMPI MODEL 720 NMS
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 Number890.5850
Classification Product Code
IPF  
Date Received11/29/1985
Decision Date 02/12/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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