FDA 510(k) Application Details - K192305

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K192305
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	3NT Medical Ltd. 22 HaMelacha St., POB 11384 Rosh HaÆAyin 4809169 IL Other 510(k) Applications for this Company
Contact	Ehud Bendory 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	08/23/2019
Decision Date	02/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review