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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K862236
Device Name MYOLAB II, MODEL ML-200
Applicant
Motion Control, Inc.
1005 S. 300 W.
Salt Lake City,  UT  84101
Applicant Contact RICHARD D LUNTZ
Correspondent
Motion Control, Inc.
1005 S. 300 W.
Salt Lake City,  UT  84101
Correspondent Contact RICHARD D LUNTZ
Regulation Number890.1375
Classification Product Code
IKN  
Date Received06/11/1986
Decision Date 08/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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