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

    MANAN GENERAL UTILITY DRAINAGE CATHETER

    K Number: K953713 · Decision Mar 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    39
    Review Days
    251

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    Basic Information

    Device Name
    MANAN GENERAL UTILITY DRAINAGE CATHETER
    K Number
    K953713
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Manan Medical Products, Inc.
    Date Received
    July 19, 1995
    Decision Date
    March 26, 1996
    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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