The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene Soft Polypropylene Mesh.
| Device ID | K163152 |
| 510k Number | K163152 |
| Device Name: | PROLENE Soft Polypropylene Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 |
| Contact | Debbie Fazen |
| Correspondent | Debbie Fazen Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-03-11 |
| Summary: | summary |