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federal_register: 2014-12297

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-12297 Medical Devices; Gastroenterology-Urology Devices; Classification of Pancreatic Drainage Stent and Delivery System Rule The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system 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 pancreatic drainage stent and delivery system 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. 2014-05-29 2014 5 https://www.federalregister.gov/documents/2014/05/29/2014-12297/medical-devices-gastroenterology-urology-devices-classification-of-pancreatic-drainage-stent-and https://www.govinfo.gov/content/pkg/FR-2014-05-29/pdf/2014-12297.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system 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...

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