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510(k) Data Aggregation

    K Number
    DEN090011
    Device Name
    HEM-AVERT PERIANAL STABILIZER
    Date Cleared
    2011-01-13

    (513 days)

    Product Code
    Regulation Number
    884.5200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hem-Avert Perianal Stabilizer is indicated for the prevention of external hemorrhoids during vaginal childbirth.
    Device Description
    This is a single use, disposable, sterile instrument. The Hem-Avert™ Perianal Stabilizer consists of three components: 1. rigid polymer base manufactured from a medical grade polycarbonate 2. centrally located cushioning pad composed of a laminate of medical grade polyester non-woven tape and medical grade polyethylene foam tape 3. two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the instrument firmly in place during delivery. The cushioning pad and adhesive strips are manufactured from materials commonly associated with medical instruments and used in medical procedures.
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