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

    BREATHTIQUE TONGUE SCRAPER

    K Number: K983087 · Decision Nov 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    150
    Registration Numbers
    151
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    BREATHTIQUE TONGUE SCRAPER
    K Number
    K983087
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Medical Arts, Inc.
    Date Received
    September 3, 1998
    Decision Date
    November 18, 1998
    Product Code
    LCN
    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
    LCN Scraper, Tongue

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