federal_register: 2015-19074

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2015-19074 Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device Rule The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the external UES compression device's classification. 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. 2015-08-04 2015 8 https://www.federalregister.gov/documents/2015/08/04/2015-19074/medical-devices-ear-nose-and-throat-devices-classification-of-the-external-upper-esophageal https://www.govinfo.gov/content/pkg/FR-2015-08-04/pdf/2015-19074.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of...

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