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

    ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)

    K Number: K896998 · Decision Jun 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    171

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    Basic Information

    Device Name
    ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
    K Number
    K896998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    S.P.K. Technology, Inc.
    Date Received
    December 12, 1989
    Decision Date
    June 1, 1990
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MCH), ordered by most recent decision date.

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    TITANIUM HEMOSTATIC CLIP

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    Other Clearances by S.P.K. Technology, Inc.

    K Number Device Name
    K896997 ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)