The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene (polypropylene) 3d Patch.
| Device ID | K181268 |
| 510k Number | K181268 |
| Device Name: | PROLENE (Polypropylene) 3D Patch |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Ethicon, Inc. Route 22 West P.O Box 151 Somerville, NJ 08876 -0151 |
| Contact | Melina Escobar |
| Correspondent | Melina Escobar Ethicon, Inc. Route 22 West P.O Box 151 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 | 2018-05-14 |
| Decision Date | 2018-07-26 |
| Summary: | summary |