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

    SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH

    K Number: K903709 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    23
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
    K Number
    K903709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    August 16, 1990
    Decision Date
    October 26, 1990
    Product Code
    GBZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBZ Catheter, Cholangiography

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