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

    DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY

    K Number: K864292 · Decision Dec 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
    K Number
    K864292
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Eye-Ko, Inc.
    Date Received
    October 31, 1986
    Decision Date
    December 29, 1986
    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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