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

    PROXIMATE LINEAR CUTTER THICK TISSUE INST.

    K Number: K892927 · Decision May 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    204
    Review Days
    35

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    Basic Information

    Device Name
    PROXIMATE LINEAR CUTTER THICK TISSUE INST.
    K Number
    K892927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    ETHICON, Inc.
    Date Received
    April 21, 1989
    Decision Date
    May 26, 1989
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

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