FDA 483 - Fresenius Medical Care Renal Therapies Group, LLC

This document is an acknowledgement letter from the FDA's Center for Devices and Radiological Health (CDRH) to Fresenius Medical Care Renal Therapies Group, LLC. It confirms the receipt of submission K233159, which pertains to several pureFLOW medical devices. The letter provides the submission number for future correspondence and indicates that the review is pending.