BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    Caphosol® Artifical Saliva (32 doses sachet box)

    K Number: K234015 · Decision Mar 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    Caphosol® Artifical Saliva (32 doses sachet box)
    K Number
    K234015
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eusa Pharma (Uk) Limited
    Date Received
    December 19, 2023
    Decision Date
    March 11, 2024
    Product Code
    LFD
    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
    LFD Saliva, Artificial

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    Other Clearances by Eusa Pharma (Uk) Limited

    K Number Device Name
    K162167 Caphosol Artifical Saliva Tablets