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

    LS9000 SUCTION BIOPSY NEEDLE

    K Number: K862749 · Decision Sep 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    LS9000 SUCTION BIOPSY NEEDLE
    K Number
    K862749
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Engineering, Inc.
    Date Received
    July 21, 1986
    Decision Date
    September 15, 1986
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

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