FDA 510(k) Application Details - K213114

Device Classification Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier   More FDA Info for this Device
510(K) Number	K213114
Device Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant	Altamira Therapeutics, Inc. 8 The Green, Ste B Dover, County Of Kent, DE 19901 US Other 510(k) Applications for this Company
Contact	Elena Cavallini 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	09/27/2021
Decision Date	06/24/2022
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