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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 K953136
Device Name RS-4M
Applicant
Rs Medical
P.O. Box 4656
Vancouver,  WA  98662
Applicant Contact MIKE MCGRAW
Correspondent
Rs Medical
P.O. Box 4656
Vancouver,  WA  98662
Correspondent Contact MIKE MCGRAW
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/06/1995
Decision Date 11/30/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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