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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 K812984
Device Name SLIMTRONICS 2000
Applicant
EMS DIST.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EMS DIST.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/26/1981
Decision Date 01/19/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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