BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE

    K Number: K042897 · Decision Nov 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    111
    Review Days
    30

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    Basic Information

    Device Name
    AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
    K Number
    K042897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    October 20, 2004
    Decision Date
    November 19, 2004
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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