FDA 510(k) Application Details - DEN130046

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130046
Device Name	REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
Applicant	SOMNA THERAPEUTICS, LLC 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	11/14/2013
Decision Date	03/06/2015
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review