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

    MANAN GENERAL UTILITY DRAINAGE CATHETER

    K Number: K980193 · Decision May 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    46
    Review Days
    127

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    Basic Information

    Device Name
    MANAN GENERAL UTILITY DRAINAGE CATHETER
    K Number
    K980193
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Device Technologies, Inc.
    Date Received
    January 20, 1998
    Decision Date
    May 27, 1998
    Product Code
    LJE
    Advisory Committee
    Unknown
    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
    LJE Catheter, Nephrostomy

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