The following data is part of a premarket notification filed by C.r. Bard Inc. with the FDA for Modified Onflex Mesh.
| Device ID | K142706 |
| 510k Number | K142706 |
| Device Name: | Modified ONFLEX Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. Bard Inc. 100 Crossings Blvd. Warwick, RI 02886 |
| Contact | Mariya Buharin |
| Correspondent | Mariya Buharin C.R. Bard Inc. 100 Crossings Blvd. Warwick, RI 02886 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-03-25 |
| Summary: | summary |