FDA 510(k) Application Details - K181396

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K181396
Device Name	Device, Anti-Snoring
Applicant	Passion for Life Healthcare (UK) Limited Pioneer House, Pioneer Business Park North Road Ellesmere Port CH65 1AD GB Other 510(k) Applications for this Company
Contact	Paul Earps Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2018
Decision Date	11/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review