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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 external compression device for internal jugular vein compression
De Novo Number DEN200017
Device Name Q-Collar
Requester
q30 sports science, llc
257 riverside avenue
westport,  CT  06880
Contact gary a. greene
Regulation Number890.3050
Classification Product Code
QNX  
Date Received03/19/2020
Decision Date 02/26/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Physical Medicine
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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