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

    PMMA CLASIC

    K Number: K955777 · Decision May 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    148

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    Basic Information

    Device Name
    PMMA CLASIC
    K Number
    K955777
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rand Scientific Corp.
    Date Received
    December 20, 1995
    Decision Date
    May 16, 1996
    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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    K952165 TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS