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

    RAMY INTEGRATED NEEDLE SYRINGE

    K Number: K972452 · Decision Jul 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    RAMY INTEGRATED NEEDLE SYRINGE
    K Number
    K972452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alshifa Medical Syringes Mfg. Co., Ltd.
    Date Received
    May 7, 1997
    Decision Date
    July 24, 1997
    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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    Other Clearances by Alshifa Medical Syringes Mfg. Co., Ltd.

    K Number Device Name
    K971664 RAMY PISTON SYRINGE