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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 K113017
Device Name SYS*STIM 240
Original Applicant
METTLER ELECTRONICS CORP.
1333 south claudina st.
anaheim,  CA  92805
Original Contact christina cayuela
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   ILY   LIH  
Date Received10/11/2011
Decision Date 06/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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