The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Sepramesh Ip Bioresorbable Barrier - Permanent Mesh.
| Device ID | K040868 |
| 510k Number | K040868 |
| Device Name: | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH |
| Classification | Mesh, Surgical |
| Applicant | GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
| Contact | Michael G Halpin |
| Correspondent | Michael G Halpin GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-06-04 |
| Summary: | summary |