FDA 510(k) Application Details - K232435

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K232435
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Shenzhen HugeMed Medical Technical Development Co., Ltd. 415, 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Cathy Shi 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	08/14/2023
Decision Date	04/26/2024
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