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

    UNITED SONICS PHACO MODULE, DF-35

    K Number: K851210 · Decision May 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    UNITED SONICS PHACO MODULE, DF-35
    K Number
    K851210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    United Sonics, Inc.
    Date Received
    March 26, 1985
    Decision Date
    May 31, 1985
    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 United Sonics, Inc.

    K Number Device Name
    K851211 PHACO PAK I
    K851298 MID LABS MVSXI
    K851212 UNITED SONICS PACO SYSTEM MODEL 3000
    K851209 CILCO/UNITED SONICS PHACE PF-9000