BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NASAL EASE ALLERGY BLOCKER

    K Number: K132520 · Decision Dec 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    141

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    Basic Information

    Device Name
    NASAL EASE ALLERGY BLOCKER
    K Number
    K132520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hi-Tech Pharmacal, Inc.
    Date Received
    August 12, 2013
    Decision Date
    December 31, 2013
    Product Code
    NUP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

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