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

    SOAKARE

    K Number: K821052 · Decision May 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    33
    Review Days
    28

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    Basic Information

    Device Name
    SOAKARE
    K Number
    K821052
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Allergan, Inc.
    Date Received
    April 15, 1982
    Decision Date
    May 13, 1982
    Product Code
    HPX
    Advisory Committee
    Unknown
    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
    HPX Lens, Contact (Polymethylmethacrylate)

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