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

    CONFIDOSE IM AUTO-INJECTOR

    K Number: K060389 · Decision Jun 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    112

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    Basic Information

    Device Name
    CONFIDOSE IM AUTO-INJECTOR
    K Number
    K060389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharma-Pen, Inc.
    Date Received
    February 14, 2006
    Decision Date
    June 6, 2006
    Product Code
    KZH
    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
    KZH Introducer, Syringe Needle

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