FDA 510(k) Application Details - K171011

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K171011
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Pentax Medical 3 Paragon Drive Montvale, NJ 07645 US Other 510(k) Applications for this Company
Contact	James W. Monroe Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2017
Decision Date	07/18/2018
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