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

    CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM

    K Number: K882105 · Decision Jul 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    2
    Review Days
    53

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    Basic Information

    Device Name
    CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
    K Number
    K882105
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Dianon Systems, Inc.
    Date Received
    May 19, 1988
    Decision Date
    July 11, 1988
    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 Dianon Systems, Inc.

    K Number Device Name
    K872597 FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE