BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    A P HARNESS

    K Number: K981860 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    372

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    Basic Information

    Device Name
    A P HARNESS
    K Number
    K981860
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paraworks Enterprise, Ltd.
    Date Received
    May 27, 1998
    Decision Date
    June 3, 1999
    Product Code
    KMK
    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
    KMK Device, Intravascular Catheter Securement

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