Device Classification Name |
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
|
510(k) Number |
K170848 |
Device Name |
Alzair Allergy Blocker |
Applicant |
Nasaleze International Ltd |
Old Castletown Road |
Douglas,
IM
Im2 1qa
|
|
Applicant Contact |
Matt Duxbury |
Correspondent |
Nasaleze International Ltd |
Old Castletown Road |
Douglas,
IM
Im2 1qa
|
|
Correspondent Contact |
Matt Duxbury |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 03/21/2017 |
Decision Date | 06/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|