FDA 510(k) Application Details - K192127

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K192127
Device Name	Device, Anti-Snoring
Applicant	Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn, NY 11201 US Other 510(k) Applications for this Company
Contact	Madubuike Okafor 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	08/06/2019
Decision Date	02/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review