The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Sepramesh Ip Bioresorbable Coating/permanent Mesh.
| Device ID | K053066 |
| 510k Number | K053066 |
| Device Name: | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
| Contact | Lisa D Crockett |
| Correspondent | Lisa D Crockett GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2005-12-19 |
| Summary: | summary |