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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 K120853
Models LG3-5100, LG3-5000, LG-5U00, LG3-5V00
Device Name NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
Original Applicant
BIONESS, INC.
25103 rye canyon loop
valencia,  CA  91355
Original Contact kim tompkins
Regulation Number882.5810
Classification Product Code
GZI  
Date Received03/21/2012
Decision Date 04/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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