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

    OPHTEC ENCLAVATION NEEDLE

    K Number: K030471 · Decision Apr 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    OPHTEC ENCLAVATION NEEDLE
    K Number
    K030471
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ophtec, USA
    Date Received
    February 12, 2003
    Decision Date
    April 17, 2003
    Product Code
    HNQ
    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
    HNQ Hook, Ophthalmic

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