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

    MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC

    K Number: K864783 · Decision Dec 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    14
    Review Days
    15

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    Basic Information

    Device Name
    MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC
    K Number
    K864783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mac Lee Medical Products
    Date Received
    December 8, 1986
    Decision Date
    December 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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