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

    SOLOS EYESITE SPONGES

    K Number: K872612 · Decision Jul 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    SOLOS EYESITE SPONGES
    K Number
    K872612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Solos Ophthalmology
    Date Received
    July 6, 1987
    Decision Date
    July 31, 1987
    Product Code
    HOZ
    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
    HOZ Sponge, Ophthalmic

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    Other Clearances by Solos Ophthalmology

    K Number Device Name
    K874334 SOLOS SINGLE USE TITANIUM TIP
    K872611 SOLOS EYESITE CAP SLEEVE
    K872620 SOLOS EYESITE DRAPES
    K872610 SOLOS EYESITE CANNULAS