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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K142432
Device Name StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
Applicant
BIONESS, INC.
25103 RYE CANYON LOOP
VALENCIA,  CA  91355
Applicant Contact Robert Schulz, RAC
Correspondent
BIONESS, INC.
25103 RYE CANYON LOOP
VALENCIA,  CA  91355
Correspondent Contact Robert Schulz, RAC
Regulation Number882.5870
Classification Product Code
GZF  
Date Received08/29/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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