Device Type ID | 2199 |
Device Name | Columns, Immunoadsorption In Extracorporeal Systems |
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 | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LQQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2199 |
Device | Columns, Immunoadsorption In Extracorporeal Systems |
Product Code | LQQ |
FDA Device Classification | Class 3 Medical Device |