BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    I.V.IRRIGATION POLE

    K Number: K915065 · Decision Feb 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    95

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    Basic Information

    Device Name
    I.V.IRRIGATION POLE
    K Number
    K915065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Medical Mfg., Inc.
    Date Received
    November 8, 1991
    Decision Date
    February 11, 1992
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by American Medical Mfg., Inc.

    K Number Device Name
    K982029 SHARPS COLLECTION CONTAINER - SAF-T-SHELL
    K961454 AMMI MAGNI-GUARD
    K915066 DISPOSABLE SKIN MARKER
    K915064 DISPOSABLE CAUTERY ABRASIVE PAD
    K915068 PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER