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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 K970051
Device Name MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
Applicant
SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD,  CA  92008 -6601
Applicant Contact DAN W MILLER
Correspondent
SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD,  CA  92008 -6601
Correspondent Contact DAN W MILLER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received01/07/1997
Decision Date 07/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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