The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Force Fiber.
| Device ID | K033654 |
| 510k Number | K033654 |
| Device Name: | FORCE FIBER |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Lynn Matos |
| Correspondent | Lynn Matos TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2004-01-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FORCE FIBER 76565784 2985950 Live/Registered |
Teleflex Incorporated 2003-12-05 |