The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Large Pore Soft Mesh And Soft Mesh Preshaped.
| Device ID | K052155 |
| 510k Number | K052155 |
| Device Name: | BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Lucinda L Fox |
| Correspondent | Lucinda L Fox C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, 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 | 2005-08-08 |
| Decision Date | 2005-10-20 |
| Summary: | summary |