Device Type ID | 2200 |
Device Name | Spermatocele, Alloplastic |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | LQS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2200 |
Device | Spermatocele, Alloplastic |
Product Code | LQS |