BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ADD-A-CATH

    K Number: K884061 · Decision Oct 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    ADD-A-CATH
    K Number
    K884061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Femcare , Ltd.
    Date Received
    September 26, 1988
    Decision Date
    October 25, 1988
    Product Code
    KOB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOB Catheter, Suprapubic (And Accessories)

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    Other Clearances by Femcare , Ltd.

    K Number Device Name
    K932465 LI VASECTOMY