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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Interferential Current Therapy
510(k) Number K883080
Device Name SYS*STIM 220
Applicant
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact ROBERT E FLEMING
Correspondent
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact ROBERT E FLEMING
Regulation Number882.5890
Classification Product Code
LIH  
Date Received07/21/1988
Decision Date 04/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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