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

    ACE ICPM SIDE PORTED NEEDLE

    K Number: K881858 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    111
    Review Days
    24

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    Basic Information

    Device Name
    ACE ICPM SIDE PORTED NEEDLE
    K Number
    K881858
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Buckman Co., Inc.
    Date Received
    May 3, 1988
    Decision Date
    May 27, 1988
    Product Code
    LXC
    Advisory Committee
    Unknown
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXC Monitor, Pressure, Intracompartmental

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