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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
De Novo Number DEN200018
Device Name eXciteOSA with remote and eXciteOSA without remote
Requester
signifier medical technologies
the triangle, 6th floor, hammersmith grove, hammersmith
london,  GB w6 0lg
Contact yasser zayni
Regulation Number872.5575
Classification Product Code
QNO  
Date Received03/24/2020
Decision Date 02/05/2021
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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