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510(k) Data Aggregation

    K Number
    K992995
    Device Name
    AROMATIC AND FLAVORED TONGUE DEPRESSOR
    Manufacturer
    AGA PLASTIC IND. COM. LTDA.
    Date Cleared
    1999-12-09

    (93 days)

    Product Code
    FMA
    Regulation Number
    880.6230
    Why did this record match?
    Product Code :

    FMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs. They are available in the following colors: Yellow. blue, orange, magenta, pink. green and red.
    Device Description
    The Aromatic and Flavored Tongue Depressor is for medical use which is comprised of a non-toxic thermoplastic material and an aromatic sweetener. The device is molded through a process of injection molding originating an article of vibrant colors, with taste and smell, 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick.
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