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

    THE CLEANER ACCESSORY

    K Number: K921882 · Decision Aug 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    5
    Review Days
    126

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    Basic Information

    Device Name
    THE CLEANER ACCESSORY
    K Number
    K921882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eaton Medical Corp.
    Date Received
    April 21, 1992
    Decision Date
    August 25, 1992
    Product Code
    LYL
    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
    LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

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    Other Clearances by Eaton Medical Corp.

    K Number Device Name
    K931718 SPIRIT SHIELD
    K904824 EASY EYES TM CONTACT LENS CLEANING MACHINE
    K871741 EASY EYES TM LENS CARRYING CASE
    K841881 EASY EYES TM LENS CARRYING CASE