The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for 3dmax Mid Anatomical Mesh.
| Device ID | K200818 |
| 510k Number | K200818 |
| Device Name: | 3DMax MID Anatomical Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 |
| Contact | Shannon Green |
| Correspondent | Shannon Green C.R. Bard, Inc. 100 Crossings Boulevard 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 | 2020-03-30 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741200793 | K200818 | 000 |
| 00801741200786 | K200818 | 000 |
| 00801741200779 | K200818 | 000 |
| 00801741200762 | K200818 | 000 |
| 00801741200755 | K200818 | 000 |
| 00801741200748 | K200818 | 000 |