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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, Diagnostic
510(k) Number K790949
Device Name GALVANIC UNIT
Applicant
Rami International Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Rami International Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.1850
Classification Product Code
ISB  
Date Received05/21/1979
Decision Date 08/16/1979
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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