FDA 510(k) Application Details - K183691

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K183691
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1782 US Other 510(k) Applications for this Company
Contact	William Goeller 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	12/31/2018
Decision Date	06/12/2019
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