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

    PROCTIGARD

    K Number: K140558 · Decision Jul 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    PROCTIGARD
    K Number
    K140558
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Pharmaceuticals, Inc.
    Date Received
    March 5, 2014
    Decision Date
    July 16, 2014
    Product Code
    PHN
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

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    Other Clearances by Access Pharmaceuticals, Inc.

    K Number Device Name
    K062795 MUGARD MUCOADHESIVE ORAL WOUND RINSE