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

    PRUITT IRRIGATION AND OCCLUSION CATHETER

    K Number: K844094 · Decision Nov 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    42

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    Basic Information

    Device Name
    PRUITT IRRIGATION AND OCCLUSION CATHETER
    K Number
    K844094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bionomy, Inc.
    Date Received
    October 18, 1984
    Decision Date
    November 29, 1984
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GBX Catheter, Irrigation

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    Other Clearances by Bionomy, Inc.

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