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

    SIMMONS SHELL

    K Number: K855105 · Decision Mar 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    21
    Review Days
    98

    Basic Information

    Device Name
    SIMMONS SHELL
    K Number
    K855105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3800
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    MIRA, INC.
    Date Received
    December 23, 1985
    Decision Date
    March 31, 1986
    Product Code
    HQT
    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
    HQT Shell, Scleral

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