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 |