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

    HEMOREST(TM)

    K Number: K864470 · Decision Jun 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    223

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    Basic Information

    Device Name
    HEMOREST(TM)
    K Number
    K864470
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Health Aid Products
    Date Received
    November 12, 1986
    Decision Date
    June 23, 1987
    Product Code
    LRL
    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
    LRL Cushion, Hemorrhoid

    Similar 510(k) Clearances

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