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

    SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

    K Number: K950806 · Decision Jun 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    21
    Review Days
    469

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    Basic Information

    Device Name
    SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
    K Number
    K950806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3340
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mira, Inc.
    Date Received
    February 22, 1995
    Decision Date
    June 5, 1996
    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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