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

    SUMMIT OPTICS SOFT CONTACT LENS CASE

    K Number: K870164 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    SUMMIT OPTICS SOFT CONTACT LENS CASE
    K Number
    K870164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Dayton Mfg. Co.
    Date Received
    January 14, 1987
    Decision Date
    February 10, 1987
    Product Code
    LRX
    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
    LRX Case, Contact Lens

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    Other Clearances by Dayton Mfg. Co.

    K Number Device Name
    K870072 SUMMIT OPTICS CONTACT LENS REMOVER