FDA 510(k) Application Details - K134003

Device Classification Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier   More FDA Info for this Device
510(K) Number	K134003
Device Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant	RHINIX APS SKAGENVEJ 21 EGAA DK-8200 DK Other 510(k) Applications for this Company
Contact	METTE MUNCH 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	12/27/2013
Decision Date	09/04/2014
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