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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
Device Name NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
Applicant
BIONESS, INC.
25103 RYE CANYON LOOP
VALENCIA,  CA  91355
Applicant Contact KIM TOMPKINS
Correspondent
BIONESS, INC.
25103 RYE CANYON LOOP
VALENCIA,  CA  91355
Correspondent Contact KIM TOMPKINS
Regulation Number882.5810
Classification Product Code
GZI  
Date Received03/21/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
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