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

    HYPODERMIC JET INJECTION APPARATUS

    K Number: K962017 · Decision Jul 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    HYPODERMIC JET INJECTION APPARATUS
    K Number
    K962017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4475
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Jet Injector Corp.
    Date Received
    May 23, 1996
    Decision Date
    July 26, 1996
    Product Code
    EGM
    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
    EGM Injector, Jet, Mechanical-Powered

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