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Hemodialysis System For Home Use

FDA product code ONW · 4 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5860
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-02-03 – 2024-11-01

To treat and provide hemodialysis therapy at home for chronic renal failure patients.

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