BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    JEJE TEETHER

    K Number: K034017 · Decision Oct 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    299

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    Basic Information

    Device Name
    JEJE TEETHER
    K Number
    K034017
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5550
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vibe 2000
    Date Received
    December 24, 2003
    Decision Date
    October 18, 2004
    Product Code
    MEF
    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
    MEF Ring, Teething, Non-Fluid Filled