The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Physiomesh Open Flexible Composite Mesh Device.
| Device ID | K141560 |
| 510k Number | K141560 |
| Device Name: | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Susan Lin |
| Correspondent | Susan Lin ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-10-23 |
| Summary: | summary |