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

    SITE DISPOSABLE CASSETTE

    K Number: K860989 · Decision May 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    SITE DISPOSABLE CASSETTE
    K Number
    K860989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Microsurgical Systems, Inc.
    Date Received
    March 17, 1986
    Decision Date
    May 6, 1986
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Microsurgical Systems, Inc.

    K Number Device Name
    K852187 SITE INFUSION CONTACT LENS W/ILLUMINATOR