federal_register: 2011-14790

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-14790 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid Rule The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 2011-06-15 2011 6 https://www.federalregister.gov/documents/2011/06/15/2011-14790/medical-devices-ear-nose-and-throat-devices-classification-of-the-wireless-air-conduction-hearing https://www.govinfo.gov/content/pkg/FR-2011-06-15/pdf/2011-14790.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...  

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