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  • Title: Medical devices; obstetrical and gynecological devices; classification of the hemorrhoid prevention pressure wedge. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2011 Apr 15; 76(73):21237-9. PubMed ID: 21513173.
    Abstract:
    The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.
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