Alzair Allergy Blocker

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

Nasaleze International Ltd

The following data is part of a premarket notification filed by Nasaleze International Ltd with the FDA for Alzair Allergy Blocker.

Pre-market Notification Details

Device IDK170848
510k NumberK170848
Device Name:Alzair Allergy Blocker
ClassificationCream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant Nasaleze International Ltd Old Castletown Road Douglas,  IM Im2 1qa
ContactMatt Duxbury
CorrespondentMatt Duxbury
Nasaleze International Ltd Old Castletown Road Douglas,  IM Im2 1qa
Product CodeNUP  
CFR Regulation Number880.5045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-21
Decision Date2017-06-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00370914030012 K170848 000

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