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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 K843583
Device Name FIRM-A-TRON MARK X
Applicant
Biotron , Ltd.
7680 Bond St.
Solon ,  OH  44139
Applicant Contact CHARLES CALABRESE
Correspondent
Biotron , Ltd.
7680 Bond St.
Solon ,  OH  44139
Correspondent Contact CHARLES CALABRESE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/11/1984
Decision Date 11/29/1984
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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