The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Composix E/x Mesh.
| Device ID | K002684 |
| 510k Number | K002684 |
| Device Name: | COMPOSIX E/X MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Canston, RI 02920 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-28 |
| Decision Date | 2000-10-11 |
| Summary: | summary |