BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    DOWN PAK

    K Number: K070246 · Decision Feb 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    DOWN PAK
    K Number
    K070246
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo Twinn B.V.
    Date Received
    January 25, 2007
    Decision Date
    February 16, 2007
    Product Code
    EKM
    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
    EKM Gutta-Percha

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