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

    OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

    K Number: K060971 · Decision Oct 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    200

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    Basic Information

    Device Name
    OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
    K Number
    K060971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omi Manufacturing Pty., Ltd.
    Date Received
    April 7, 2006
    Decision Date
    October 24, 2006
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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    Other Clearances by Omi Manufacturing Pty., Ltd.

    K Number Device Name
    K032242 PERSONNA PLUS SAFETY SCALPEL SYSTEM