The following data is part of a premarket notification filed by Teleflex Medical Incorporated with the FDA for Force Fiber White And White/blue, White/black, Blue, And White/green Sutures; Force Fiber Orthotape Suture; Bondek Suture And Bondek Plus Suture; Monodek Suture; Polyglytone*6211 Suture.
| Device ID | K181774 |
| 510k Number | K181774 |
| Device Name: | Force Fiber White And White/Blue, White/Black, Blue, And White/Green Sutures; Force Fiber OrthoTape Suture; Bondek Suture And Bondek Plus Suture; Monodek Suture; Polyglytone*6211 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 |
| Subsequent Product Code | GAM |
| Subsequent Product Code | NEW |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-10-10 |
| Summary: | summary |