Device Type ID | 4114 |
Device Name | Fluid, Hysteroscopy |
Review Panel | Obstetrics/Gynecology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LTA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4114 |
Device | Fluid, Hysteroscopy |
Product Code | LTA |
FDA Device Classification | Class 3 Medical Device |