NASAL EASE ALLERGY BLOCKER

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

HI-TECH PHARMACAL, INC.

The following data is part of a premarket notification filed by Hi-tech Pharmacal, Inc. with the FDA for Nasal Ease Allergy Blocker.

Pre-market Notification Details

Device IDK132520
510k NumberK132520
Device Name:NASAL EASE ALLERGY BLOCKER
ClassificationCream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant HI-TECH PHARMACAL, INC. 369 BAYVIEW AVE Amityville,  NY  11701
ContactGary April
CorrespondentGary April
HI-TECH PHARMACAL, INC. 369 BAYVIEW AVE Amityville,  NY  11701
Product CodeNUP  
CFR Regulation Number880.5045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-12-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.