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

    BURR, CORNEAL, BATTERY-POWERED

    K Number: K950520 · Decision May 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    46
    Review Days
    85

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    Basic Information

    Device Name
    BURR, CORNEAL, BATTERY-POWERED
    K Number
    K950520
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aaron Medical Industries
    Date Received
    February 6, 1995
    Decision Date
    May 2, 1995
    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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