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

    PALLIKARIS BRUSH

    K Number: K960261 · Decision Mar 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    43
    Review Days
    53

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    Basic Information

    Device Name
    PALLIKARIS BRUSH
    K Number
    K960261
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alcon Laboratories, Inc.
    Date Received
    January 18, 1996
    Decision Date
    March 11, 1996
    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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