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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K951350
Device Name MUSCLESENSE ELECTROMYOGRAPHY DEVICE
Applicant
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008 -6601
Applicant Contact DAN W MILLER
Correspondent
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008 -6601
Correspondent Contact DAN W MILLER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/24/1995
Decision Date 06/23/1995
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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