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

    HAMACHER BULLET POINT OPHTHALMIC NEEDLE

    K Number: K872200 · Decision Jun 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    10
    Review Days
    17

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    Basic Information

    Device Name
    HAMACHER BULLET POINT OPHTHALMIC NEEDLE
    K Number
    K872200
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    R. J. Doyle, Inc.
    Date Received
    June 8, 1987
    Decision Date
    June 25, 1987
    Product Code
    HMX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HMX Cannula, Ophthalmic

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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
    K894873 16 GA X 10 BULLET POINT NEEDLE