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

    IMPLANT, SILICONE AND TANTALUM

    K Number: K760550 · Decision Oct 5, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    IMPLANT, SILICONE AND TANTALUM
    K Number
    K760550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Medical Instrument Research Assoc., Inc.
    Date Received
    August 30, 1976
    Decision Date
    October 5, 1976
    Product Code
    HQJ
    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
    HQJ Implant, Absorbable, (Scleral Buckling Methods)

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