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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 K870774
Device Name TRU-STIM MUSCLE STIMULATOR
Applicant
Briefcase, Inc.
125 Hazel Ave.
Mill Valley,  CA  94941
Applicant Contact CHARLES A KANTER
Correspondent
Briefcase, Inc.
125 Hazel Ave.
Mill Valley,  CA  94941
Correspondent Contact CHARLES A KANTER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/26/1987
Decision Date 03/18/1987
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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