The following data is part of a premarket notification filed by Nasaleze International Ltd with the FDA for Alzair Allergy Blocker.
| Device ID | K170848 |
| 510k Number | K170848 |
| Device Name: | Alzair Allergy Blocker |
| 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 | 2017-03-21 |
| Decision Date | 2017-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370914030012 | K170848 | 000 |