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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 upper esophageal sphincter (ues) compression device
De Novo Number DEN130046
Device Name REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
Requester
somna therapeutics, llc
w175 n11081 stonewood dr.
germantown,  WI  53022
Contact james s. miller
Regulation Number874.5900
Classification Product Code
PKA  
Date Received11/14/2013
Decision Date 03/06/2015
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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