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 Code | NII |
Premarket Review |
Office of 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 |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |