Definition: THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
| Device Type ID | 1644 |
| Device Name | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Regulation Description | Medical Recirculating Air Cleaner. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5045 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1644 |
| Device | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Product Code | NUP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Recirculating Air Cleaner. |
| CFR Regulation Number | 880.5045 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NASALEZE INTERNATIONAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RHINIX APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |