FDA 510(k) Application Details - K161298

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K161298
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	SHENYANG SHENDA ENDOSCOPE CO., LTD NO.123 HEZUO STREET, DADONG DISTRICT SHENYANG 110044 CN Other 510(k) Applications for this Company
Contact	GAO FENG 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	05/09/2016
Decision Date	08/25/2017
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