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

    TITANIUM HEMOSTATIC CLIP

    K Number: K972745 · Decision Oct 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    TITANIUM HEMOSTATIC CLIP
    K Number
    K972745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eisner USA, Inc.
    Date Received
    July 23, 1997
    Decision Date
    October 21, 1997
    Product Code
    MCH
    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
    MCH Clip, Hemostatic

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