BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KOLBERG OPHTHALMIC CONFORMER

    K Number: K945110 · Decision Jan 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    KOLBERG OPHTHALMIC CONFORMER
    K Number
    K945110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3130
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kolberg Ocular Products, Inc.
    Date Received
    October 18, 1994
    Decision Date
    January 13, 1995
    Product Code
    HQN
    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
    HQN Conformer, Ophthalmic

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