BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CLEAR EYE GARTER SHIELD

    K Number: K880489 · Decision Aug 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    6
    Review Days
    186

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    Basic Information

    Device Name
    CLEAR EYE GARTER SHIELD
    K Number
    K880489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Eye Garter Company, Inc.
    Date Received
    February 4, 1988
    Decision Date
    August 8, 1988
    Product Code
    HOY
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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    Other Clearances by Eye Garter Company, Inc.

    K Number Device Name
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