AllerBlock Junior

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 Allerblock Junior.

Pre-market Notification Details

Device IDK201734
510k NumberK201734
Device Name:AllerBlock Junior
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 Received2020-06-25
Decision Date2021-03-26

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