The following data is part of a premarket notification filed by Teleflex Medical Incorporated with the FDA for Force Fiber Fusion Suture.
| Device ID | K172016 |
| 510k Number | K172016 |
| Device Name: | Force Fiber Fusion Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield, MA 02048 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva Teleflex Medical Incorporated 375 Forbes Boulevard Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704735215 | K172016 | 000 |
| 04026704735242 | K172016 | 000 |
| 04026704735235 | K172016 | 000 |
| 04026704735228 | K172016 | 000 |
| 04026704735204 | K172016 | 000 |
| 04026704735198 | K172016 | 000 |
| 04026704735181 | K172016 | 000 |
| 04026704735174 | K172016 | 000 |