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

    SOLOS SINGLE USE TITANIUM TIP

    K Number: K874334 · Decision Jan 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    SOLOS SINGLE USE TITANIUM TIP
    K Number
    K874334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Solos Ophthalmology
    Date Received
    October 22, 1987
    Decision Date
    January 11, 1988
    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 Solos Ophthalmology

    K Number Device Name
    K872611 SOLOS EYESITE CAP SLEEVE
    K872612 SOLOS EYESITE SPONGES
    K872620 SOLOS EYESITE DRAPES
    K872610 SOLOS EYESITE CANNULAS