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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 K240328
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
Ste 803
Tampa,  FL  33618
Correspondent Contact Darren Scheer
Classification Product Code
QNO  
Date Received02/05/2024
Decision Date 05/16/2024
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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