K170848 is an FDA 510(k) clearance for the Alzair Allergy Blocker. This device is classified as a Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (Class II - Special Controls, product code NUP).
Submitted by Nasaleze International, Ltd. (Douglas, IM). The FDA issued a Cleared decision on June 14, 2017, 85 days after receiving the submission on March 21, 2017.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 880.5045. The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens..
| 510(k) Number | K170848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2017 |
| Decision Date | June 14, 2017 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NUP - Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |
| Definition | The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens. |