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

    MULTI-PURPOSE MEDICAL TUBE HOLDER

    K Number: K963365 · Decision Oct 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    MULTI-PURPOSE MEDICAL TUBE HOLDER
    K Number
    K963365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Byrd Medical Devices, Inc.
    Date Received
    August 27, 1996
    Decision Date
    October 11, 1996
    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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