FDA 510(k) Application Details - K181219

Device Classification Name	Dilator, Nasal   More FDA Info for this Device
510(K) Number	K181219
Device Name	Dilator, Nasal
Applicant	Cpapnea Medical Supply 10443 N Cave Creek Rd, Suite 110 Phoenix, AZ 85020 US Other 510(k) Applications for this Company
Contact	Sal T. Hakim Other 510(k) Applications for this Contact
Regulation Number	874.3900   More FDA Info for this Regulation Number
Classification Product Code	LWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2018
Decision Date	08/03/2018
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