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U.S. Department of Health and Human Services

Product Classification

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Device disinfectant, dialysate delivery system
Regulation Description High permeability hemodialysis system.
Definition Disinfectant intended for reprocessing dialysate delivery systems.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodeNII
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
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
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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