BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    STERILE BLUNT FOR SINGLE USE

    K Number: K120420 · Decision Oct 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    2
    Review Days
    251

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    Basic Information

    Device Name
    STERILE BLUNT FOR SINGLE USE
    K Number
    K120420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Double Dove Industrial Co., Ltd.
    Date Received
    February 10, 2012
    Decision Date
    October 18, 2012
    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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    Other Clearances by Shanghai Double Dove Industrial Co., Ltd.

    K Number Device Name
    K090929 STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE