The following data is part of a premarket notification filed by Nasaleze International Ltd with the FDA for Allerblock Junior.
| Device ID | K201734 |
| 510k Number | K201734 |
| Device Name: | AllerBlock Junior |
| Classification | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Applicant | Nasaleze International Ltd Old Castletown Road Douglas, IM Im2 1qa |
| Contact | Matt Duxbury |
| Correspondent | Matt Duxbury Nasaleze International Ltd Old Castletown Road Douglas, IM Im2 1qa |
| Product Code | NUP |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2021-03-26 |