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

    HARD CONTACT LENS SOAKING SOLUTION

    K Number: K853811 · Decision Dec 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    6
    Review Days
    96

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    Basic Information

    Device Name
    HARD CONTACT LENS SOAKING SOLUTION
    K Number
    K853811
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Maurry Biological Co.
    Date Received
    September 11, 1985
    Decision Date
    December 16, 1985
    Product Code
    HPX
    Advisory Committee
    Unknown
    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
    HPX Lens, Contact (Polymethylmethacrylate)

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    Other Clearances by Maurry Biological Co.

    K Number Device Name
    K861712 WETTING & SOAKING HARD CONTACT LENS SOLUTION
    K853808 HARD CONTACT LENS CLEANING & SOAKING SOLUTION
    K853809 DAILY HARD CONTACT LENS CLEANER
    K853810 WETTING SOLUTION FOR HARD CONTACT LENSES
    K853807 ALL-IN-ONE HARD CONTACT LENS SOLUTION