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

    ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE

    K Number: K800408 · Decision Apr 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    21
    Review Days
    62

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    Basic Information

    Device Name
    ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
    K Number
    K800408
    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
    GAA
    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
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by A.D.T. Lab Industries

    K Number Device Name
    K812297 A.D.T. PROCEDURES TRAY
    K801754 ADT BONE MARROW ASPIRATION NEEDLE
    K801753 ADT BONE MARROW BIOPSY-ASPIR. NEELDE
    K800410 ADT BONE MARROW BIOPSY-ASPIRATION TRAY
    K800417 ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL
    K800411 ASPIRATION TRAY W/FERRIS DISP. ILLINOIS
    K800418 ADT DISPOSABLE THIN NEEDLE ASPIRATION
    K800414 ADT SOFT TISSUE BIOPSY TRAY
    K800409 ADT BONE MARROW BIOPSY ASPIRATION TRAY
    K800412 ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW
    Search all 21 clearances from A.D.T. Lab Industries →