NASAL EASE ALLERGY BLOCKER— 510(k) K132520

Name: FDA 510(k) clearance K132520
Creator: U.S. Food and Drug Administration
Published: 2013-12-31

Substantially Equivalent

Hi-Tech Pharmacal, Inc.

FDA 510(k) clearance K132520 for NASAL EASE ALLERGY BLOCKER, Substantially Equivalent on 2013-12-31. Applicant: Hi-Tech Pharmacal, Inc.. Device class: 2.

Clearance details

Applicant: Hi-Tech Pharmacal, Inc.
Product code: Code NUP
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 2013-08-12
Decision date: 2013-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amityville, NY, US

Download summary PDF View on FDA.gov ↗

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