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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 K190047
Device Name StimRouter Neuromodulation System
Applicant
Bioness, Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Sageev George
Correspondent
Bioness, Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Sageev George
Regulation Number882.5870
Classification Product Code
GZF  
Date Received01/09/2019
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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