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

    16 GA X 10 BULLET POINT NEEDLE

    K Number: K894873 · Decision Sep 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    10
    Review Days
    52

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    Basic Information

    Device Name
    16 GA X 10 BULLET POINT NEEDLE
    K Number
    K894873
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    R. J. Doyle, Inc.
    Date Received
    August 1, 1989
    Decision Date
    September 22, 1989
    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 R. J. Doyle, Inc.

    K Number Device Name
    K894878 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
    K894881 20GA X 7-1/2 THREADING BULLET POINT NEEDLE
    K894882 INFILTRATION PUMP SYRINGE
    K894879 16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
    K894880 16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
    K894872 16 GA X 6 BULLET POINT NEEDLE
    K894874 14 INCH BULLET POINT NEEDLE
    K894875 20GA X 7-1/2 THREADING BULLET POINT NEEDLE
    K872200 HAMACHER BULLET POINT OPHTHALMIC NEEDLE