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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 K962462
Device Name MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
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 Number890.5850
Classification Product Code
IPF  
Date Received06/25/1996
Decision Date 09/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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