The following data is part of a premarket notification filed by Teleflex Medical Incorporated with the FDA for Force Fiber Suture.
| Device ID | K191268 |
| 510k Number | K191268 |
| Device Name: | Force Fiber Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield, MA 02048 |
| Contact | Andrea Curria |
| Correspondent | Andrea Curria Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-06-11 |