The following data is part of a premarket notification filed by Rhinix Aps with the FDA for Rhinix Nasal Filter.
| Device ID | K134003 |
| 510k Number | K134003 |
| Device Name: | RHINIX NASAL FILTER |
| Classification | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Applicant | RHINIX APS SKAGENVEJ 21 Egaa, DK Dk-8200 |
| Contact | Mette Munch |
| Correspondent | Mette Munch RHINIX APS SKAGENVEJ 21 Egaa, DK Dk-8200 |
| Product Code | NUP |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-27 |
| Decision Date | 2014-09-04 |
| Summary: | summary |