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

    MINIJECT

    K Number: K991888 · Decision Aug 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    MINIJECT
    K Number
    K991888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spartan Ultrasonics, Inc.
    Date Received
    June 2, 1999
    Decision Date
    August 25, 1999
    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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    Other Clearances by Spartan Ultrasonics, Inc.

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