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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name block, bite
510(k) Number K221469
Device Name PATI (Protector Against Tongue Injury)
NeuroVice, LLC
7928 Woodcross Way
Wake Forest,  NC  27587
Applicant Contact Ashlyn Sanders
Gilero, LLC
635 Davis Drive, Suite 100
Morrisville,  NC  27560
Correspondent Contact John Hayes
Regulation Number882.5070
Classification Product Code
Date Received05/20/2022
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No