Device Type ID | 5921 |
Device Name | Gauze, External (with Drug/biologic/animal Source Material) |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | GER |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5921 |
Device | Gauze, External (with Drug/biologic/animal Source Material) |
Product Code | GER |