The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Modification Of Prolene (polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh.
| Device ID | K984220 |
| 510k Number | K984220 |
| Device Name: | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Gregory R Jones |
| Correspondent | Gregory R Jones ETHICON, INC. P.O BOX 151, ROUTE 22 WEST 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 | 1998-11-25 |
| Decision Date | 1999-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705031048935 | K984220 | 000 |