FDA 510(k) Application Details - K222587

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K222587
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34 Mississauga L4Z 3L3 CA Other 510(k) Applications for this Company
Contact	Tammy Mui 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	08/26/2022
Decision Date	07/28/2023
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