FDA 510(k) Application Details - K053625

Device Classification Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier   More FDA Info for this Device
510(K) Number	K053625
Device Name	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant	TRUTEK CORP 80 WEST END AVE. SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	ASHOK WAHL 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	12/28/2005
Decision Date	02/22/2006
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