BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX

    K Number: K853731 · Decision Oct 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    75
    Review Days
    42

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    Basic Information

    Device Name
    HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
    K Number
    K853731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gish Biomedical, Inc.
    Date Received
    September 6, 1985
    Decision Date
    October 18, 1985
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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