Device Type ID | 1874 |
Device Name | Dialyzer, Parallel Flow |
Regulation Description | Hemodialysis System And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
Submission Type | 510(k) |
CFR Regulation Number | 876.5820 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FJG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |