BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PLASTIC OR GLASS MAGNIFIER

    K Number: K820375 · Decision Jun 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    PLASTIC OR GLASS MAGNIFIER
    K Number
    K820375
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5540
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Gazelle Corp.
    Date Received
    February 9, 1982
    Decision Date
    June 14, 1982
    Product Code
    HJF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HJF Magnifier, Hand-Held, Low-Vision

    Other Clearances by Gazelle Corp.

    K Number Device Name
    K844716 MAGNIFYING SPECTACLES W/PLASTIC LENSES