Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact