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

    SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT

    K Number: K852386 · Decision Sep 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    7
    Review Days
    91

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    Basic Information

    Device Name
    SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
    K Number
    K852386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Barnes-Hind, Inc.
    Date Received
    June 5, 1985
    Decision Date
    September 4, 1985
    Product Code
    LPN
    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
    LPN Accessories, Soft Lens Products

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