The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Tbd Ethicon Mesh.
| Device ID | K082216 |
| 510k Number | K082216 |
| Device Name: | TBD ETHICON MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON INC. ROUTE 22 WEST PO BOX 151 Somerville, NJ 08876 |
| Contact | Bryan A Lisa |
| Correspondent | Bryan A Lisa ETHICON INC. ROUTE 22 WEST PO BOX 151 Somerville, NJ 08876 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2008-09-05 |
| Summary: | summary |