| Device Type ID | 5760 |
| Device Name | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Regulation Description | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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) |
| CFR Regulation Number | 878.5035 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NBY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5760 |
| Device | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Product Code | NBY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture. |
| CFR Regulation Number | 878.5035 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LSI SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OMNIA SPA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RIVERPOINT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SURGICAL SPECIALTIES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |