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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 K162407
Device Name L300 Go System
Applicant
BIONESS INC.
25103 RYE CANYON LOOP
VALENCIA,  CA  91355
Applicant Contact MERCEDES BAYANI
Correspondent
MDJD CONSULTING
5905 WARM MIST LN.
DALLAS,  TX  75248
Correspondent Contact EVAN L. ROSENFELD
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received08/29/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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