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

    DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

    K Number: K861153 · Decision Apr 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    18
    Review Days
    28

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    Basic Information

    Device Name
    DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
    K Number
    K861153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Exel Intl.
    Date Received
    March 26, 1986
    Decision Date
    April 23, 1986
    Product Code
    FMF
    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
    FMF Syringe, Piston

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