The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Force Fiber Polyethylene Nonabsorbable Suture.
| Device ID | K063778 |
| 510k Number | K063778 |
| Device Name: | FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 120 Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 120 Bannockburn, IL 60015 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853541006105 | K063778 | 000 |