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

    VISI-DRAPE OPHTHALMIC DRAPES

    K Number: K902857 · Decision Jul 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    49
    Review Days
    32

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    Basic Information

    Device Name
    VISI-DRAPE OPHTHALMIC DRAPES
    K Number
    K902857
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Visitec Co.
    Date Received
    June 29, 1990
    Decision Date
    July 31, 1990
    Product Code
    HMY
    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
    HMY Keratome, Battery-Powered

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