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U.S. Department of Health and Human Services

Product Classification
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Device hemodialysis system for home use
Regulation Description High permeability hemodialysis system.
Definition To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Physical State Complex machine consisting of pumps, monitors, and tubing.
Technical Method A machine that dialyzes the patient's blood.
Target Area Connects to the patient's blood stream
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeONW
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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