BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SAFE-T-CAP NEEDLE COVER

    K Number: K896219 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    SAFE-T-CAP NEEDLE COVER
    K Number
    K896219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4730
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Ausmedics Pty , Ltd.
    Date Received
    October 27, 1989
    Decision Date
    January 22, 1990
    Product Code
    DZM
    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
    DZM Needle, Dental

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    Other Clearances by Ausmedics Pty , Ltd.

    K Number Device Name
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