BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AMOILS EPITHELIAL SCRUBBER

    K Number: K962989 · Decision Jan 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    161

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    Basic Information

    Device Name
    AMOILS EPITHELIAL SCRUBBER
    K Number
    K962989
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S. Percy Amoils
    Date Received
    August 1, 1996
    Decision Date
    January 9, 1997
    Product Code
    HOG
    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
    HOG Burr, Corneal, Battery-Powered

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