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

    TRI-STAR UNIVERSAL I/A PHACO PAK

    K Number: K953359 · Decision Oct 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    2
    Review Days
    92

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    Basic Information

    Device Name
    TRI-STAR UNIVERSAL I/A PHACO PAK
    K Number
    K953359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-Star Ophthalmic
    Date Received
    July 17, 1995
    Decision Date
    October 17, 1995
    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 Tri-Star Ophthalmic

    K Number Device Name
    K914229 PHACO TIP