federal_register: 2011-9141

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-9141 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge Rule 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. 2011-04-15 2011 4 https://www.federalregister.gov/documents/2011/04/15/2011-9141/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-hemorrhoid-prevention https://www.govinfo.gov/content/pkg/FR-2011-04-15/pdf/2011-9141.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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