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

    OCULAR IRRIGATING CANNULA

    K Number: K831532 · Decision Jul 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    OCULAR IRRIGATING CANNULA
    K Number
    K831532
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Dey Laboratories, Inc.
    Date Received
    May 13, 1983
    Decision Date
    July 12, 1983
    Product Code
    HMX
    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
    HMX Cannula, Ophthalmic

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