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

    ADT DISPOSABLE THIN NEEDLE ASPIRATION

    K Number: K800418 · Decision Apr 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    21
    Review Days
    62

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    Basic Information

    Device Name
    ADT DISPOSABLE THIN NEEDLE ASPIRATION
    K Number
    K800418
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    A.D.T. Lab Industries
    Date Received
    February 26, 1980
    Decision Date
    April 28, 1980
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

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    K800410 ADT BONE MARROW BIOPSY-ASPIRATION TRAY
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    K800411 ASPIRATION TRAY W/FERRIS DISP. ILLINOIS
    K800414 ADT SOFT TISSUE BIOPSY TRAY
    K800408 ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
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    K800412 ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW
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