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

    DISPOSABLE 1CC SYRINGE WITH LUER LOCK

    K Number: K945588 · Decision Feb 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    28
    Review Days
    88

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    Basic Information

    Device Name
    DISPOSABLE 1CC SYRINGE WITH LUER LOCK
    K Number
    K945588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interventional Therapeutics Corp.
    Date Received
    November 14, 1994
    Decision Date
    February 10, 1995
    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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