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

    US PLUS-PAK(R) SURGICAL SYSTEM

    K Number: K863209 · Decision Sep 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    18
    Review Days
    19

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    Basic Information

    Device Name
    US PLUS-PAK(R) SURGICAL SYSTEM
    K Number
    K863209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ipax, Inc.
    Date Received
    August 20, 1986
    Decision Date
    September 8, 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 Ipax, Inc.

    K Number Device Name
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