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

    SCLERAL SHELL

    K Number: K970327 · Decision Jul 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    SCLERAL SHELL
    K Number
    K970327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3800
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Southwest Artificial Eyes, Inc.
    Date Received
    January 28, 1997
    Decision Date
    July 7, 1997
    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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    Other Clearances by Southwest Artificial Eyes, Inc.

    K Number Device Name
    K970318 OCULAR CONFORMER