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

    SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES

    K Number: K874681 · Decision Feb 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    602
    Registration Numbers
    602
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
    K Number
    K874681
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Klockner Contract Packaging, Inc.
    Date Received
    November 13, 1987
    Decision Date
    February 5, 1988
    Product Code
    HQG
    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
    HQG Lens, Spectacle, Non-Custom (Prescription)

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