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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
510(k) Number K223446
Device Name eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Applicant
Signifier Medical Technologies Ltd
5-17 Hammersmith Grove
London,  GB W6 0LG
Applicant Contact Yasser Zayni
Correspondent
RegChoice LLC
13014 N. Dale Mabry Hwy STE 803
Tampa,  FL  33618
Correspondent Contact Darren Scheer
Regulation Number872.5575
Classification Product Code
QNO  
Date Received11/15/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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