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 |