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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, neuromuscular, external functional
510(k) Number K173682
Device Name L300 Go System
Bioness, Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Mercedes Bayani
Bioness, Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Mary Dadone
Regulation Number882.5810
Classification Product Code
Subsequent Product Code
Date Received12/01/2017
Decision Date 03/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No