K201734 is an FDA 510(k) clearance for the AllerBlock Junior. 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 March 26, 2021, 274 days after receiving the submission on June 25, 2020.
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 | K201734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 274 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. |