The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Force Fiber Blue Co-braided Polyethylene Nonabsorbable Surgical Suture.
| Device ID | K040472 |
| 510k Number | K040472 |
| Device Name: | FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | TELEFLEX MEDICAL 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Angela Tran |
| Correspondent | Angela Tran TELEFLEX MEDICAL 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-24 |
| Decision Date | 2004-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304464940 | K040472 | 000 |
| 70887868226150 | K040472 | 000 |