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

    MedActive Oral Gel and Spray

    K Number: K152201 · Decision Dec 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    146

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    Basic Information

    Device Name
    MedActive Oral Gel and Spray
    K Number
    K152201
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medactive Oral Pharmaceuticals, LLC
    Date Received
    August 6, 2015
    Decision Date
    December 30, 2015
    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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