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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 K862685
Device Name MUSCLE MASTER (BIPOLAR STIMULATOR)
Applicant
MODERN SYSTEMS TECHNOLOGY, INC.
P.O. BOX 87
BEAVERTON,  OR  97075
Applicant Contact VAN DIJK
Correspondent
MODERN SYSTEMS TECHNOLOGY, INC.
P.O. BOX 87
BEAVERTON,  OR  97075
Correspondent Contact VAN DIJK
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/15/1986
Decision Date 11/25/1986
Decision Substantially Equivalent (SESE)
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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