FDA 510(k) Application Details - K201734

Device Classification Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier   More FDA Info for this Device
510(K) Number	K201734
Device Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant	Nasaleze International Ltd Old Castletown Road Douglas Im2 1qa IM Other 510(k) Applications for this Company
Contact	Matt Duxbury Other 510(k) Applications for this Contact
Regulation Number	880.5045   More FDA Info for this Regulation Number
Classification Product Code	NUP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2020
Decision Date	03/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review