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

    STAY-PUT IMPREGNATED

    K Number: K041023 · Decision Jun 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    STAY-PUT IMPREGNATED
    K Number
    K041023
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coltene/Whaledent GmbH & Co. KG
    Date Received
    April 20, 2004
    Decision Date
    June 15, 2004
    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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    Other Clearances by Coltene/Whaledent GmbH & Co. KG

    K Number Device Name
    K032662 GUTTAFLOW