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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K161893
Device Name Neuromonitoring Kit
Applicant
SI-BONE, INC.
3055 OLIN AVE, SUITE 2200
SAN JOSE,  CA  95128
Applicant Contact ROXANNE DUBOIS
Correspondent
SI-BONE, INC.
3055 OLIN AVE, SUITE 2200
SAN JOSE,  CA  95128
Correspondent Contact ROXANNE DUBOIS
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received07/11/2016
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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