BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    COOL EYE(TM) EYE PROTECTOR

    K Number: K881135 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    COOL EYE(TM) EYE PROTECTOR
    K Number
    K881135
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Cool Eyes, Inc.
    Date Received
    March 16, 1988
    Decision Date
    July 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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