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

    SHL DISPOSABLE AUTOINJECTOR

    K Number: K050434 · Decision Jun 24, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    122

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    Basic Information

    Device Name
    SHL DISPOSABLE AUTOINJECTOR
    K Number
    K050434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shl Medical, USA
    Date Received
    February 22, 2005
    Decision Date
    June 24, 2005
    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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    Other Clearances by Shl Medical, USA

    K Number Device Name
    K060141 DAI-R