BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇲 Isle of Man

    Alzair Allergy Blocker

    K Number: K170848 · Decision Jun 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    Alzair Allergy Blocker
    K Number
    K170848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nasaleze International, Ltd.
    Date Received
    March 21, 2017
    Decision Date
    June 14, 2017
    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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    Other Clearances by Nasaleze International, Ltd.

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