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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Upper Esophageal Sphincter (Ues) Compression Device
510(k) Number K173934
Device Name Reza Band, Reflux Band
Applicant
Somna Therapeutics, L.L.C.
W175 N11081 StoneWood Dr.
Germantown,  WI  53022
Applicant Contact James S. Miller
Correspondent
Somna Therapeutics, L.L.C.
W175 N11081 StoneWood Dr.
Germantown,  WI  53022
Correspondent Contact James S. Miller
Regulation Number874.5900
Classification Product Code
PKA  
Date Received12/26/2017
Decision Date 04/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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