The following data is part of a premarket notification filed by Davol Inc., Sub. C.r. Bard, Inc. with the FDA for Bard 3dmax Mesh.
| Device ID | K081010 |
| 510k Number | K081010 |
| Device Name: | BARD 3DMAX MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Stephanie Baker |
| Correspondent | Stephanie Baker DAVOL INC., SUB. 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 | 2008-04-09 |
| Decision Date | 2008-10-07 |
| Summary: | summary |