FDA 510(k) Application Details - K173934

Device Classification Name	More FDA Info for this Device
510(K) Number	K173934
Device Name	Reza Band, Reflux Band
Applicant	Somna Therapeutics, L.L.C. W175 N11081 StoneWood Dr. Germantown, WI 53022 US Other 510(k) Applications for this Company
Contact	James S. Miller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2017
Decision Date	04/13/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review