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

    OCUCARE ULTRASOUND TIP & FREEDOM PACK

    K Number: K834543 · Decision Mar 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    99

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    Basic Information

    Device Name
    OCUCARE ULTRASOUND TIP & FREEDOM PACK
    K Number
    K834543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intermedics Intraocular, Inc.
    Date Received
    December 8, 1983
    Decision Date
    March 16, 1984
    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 Intermedics Intraocular, Inc.

    K Number Device Name
    K862070 INTER-SHARP
    K841730 BAILEY LENS SHOOTER
    K832525 IRRIGATION/ASPIRATION PACK