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

    HENKE JECT PRESSURE SYRINGE

    K Number: K830524 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    HENKE JECT PRESSURE SYRINGE
    K Number
    K830524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew, Mpl Division
    Date Received
    February 17, 1983
    Decision Date
    March 24, 1983
    Product Code
    EJI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJI Syringe, Cartridge

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