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

    AN3500 WORTH DRAIN

    K Number: K872457 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    AN3500 WORTH DRAIN
    K Number
    K872457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    H.W. Andersen Products, Inc.
    Date Received
    June 23, 1987
    Decision Date
    July 21, 1987
    Product Code
    GBS
    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
    GBS Catheter, Ventricular, General & Plastic Surgery

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    Other Clearances by H.W. Andersen Products, Inc.

    K Number Device Name
    K935688 AN-10S ANDERSEN TUBE WITH STYLET
    K872458 AN3200 DOUBILET DRAIN
    K872460 AN3000 MAHONEY DRAIN
    K872459 AN3100 MULHOLLAND DRAIN