Device Classification Name |
cream, nasal, topical, mechanical allergen particle barrier
|
510(k) Number |
K134003 |
Device Name |
RHINIX NASAL FILTER |
Applicant |
RHINIX APS |
SKAGENVEJ 21 |
EGAA,
DK
DK-8200
|
|
Applicant Contact |
METTE MUNCH |
Correspondent |
RHINIX APS |
SKAGENVEJ 21 |
EGAA,
DK
DK-8200
|
|
Correspondent Contact |
METTE MUNCH |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 12/27/2013 |
Decision Date | 09/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01699165
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|