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

    SILASTIC SCLERAL SPONGE II W/CIRCLING BD

    K Number: K800140 · Decision Mar 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    31
    Review Days
    42

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    Basic Information

    Device Name
    SILASTIC SCLERAL SPONGE II W/CIRCLING BD
    K Number
    K800140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3340
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    January 21, 1980
    Decision Date
    March 3, 1980
    Product Code
    HQX
    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
    HQX Implant, Orbital, Extra-Ocular

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