Advisory Committees
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Briefing Materials (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting)
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Related Briefing Documents (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting)
Background Information (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting) (PDF - 49KB)Definitions and Nomenclature (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting) (PDF - 67KB)Ultrafiltration Devices (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting) (PDF - 89KB)Clinical Management of Fluid Overload (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting) (PDF - 1.7MB)Clinical Management and Treatment Options In Heart Failure (June 10, 2009: Gastroenterology-Urology Devices Panel Meeting) (PDF - 402KB)Guidance for Industry and CDRH Reviewers: Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems (PDF Version) (PDF - 86KB)Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions Guidance for Industry and CDRH Reviewers: Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers
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