The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh.
| Device ID | K962530 |
| 510k Number | K962530 |
| Device Name: | PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John D Paulson, Ph.d. |
| Correspondent | John D Paulson, Ph.d. 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 | 1996-06-28 |
| Decision Date | 1996-08-09 |
| Summary: | summary |