BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇫🇷 France

    EXPAZEN

    K Number: K150423 · Decision Jul 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    139

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    Basic Information

    Device Name
    EXPAZEN
    K Number
    K150423
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Produits Dentaires Pierre Rolland (Acteon Group)
    Date Received
    February 19, 2015
    Decision Date
    July 8, 2015
    Product Code
    MVL
    Advisory Committee
    Unknown
    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
    MVL Cord, Retraction

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