483
Baxter Healthcare Corporation, Renal DivisionBaxter Healthcare Corporation, Renal Division – FDA 483
Record Details
This document is a 510(k) summary for Baxter Healthcare Corporation, Renal Division, located in McGaw Park, IL. It describes the Ultra Set CAPD Disposable Disconnect Y-Set, a peritoneal dialysis system accessory. The submission aims to demonstrate substantial equivalence to previously cleared devices for drainage and infusion of PD solution.
- Product type
- device
- Office
- Human Foods Program
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ID · f35e30e2-6136-4c00-ab36-8309e58de893
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