The following data is part of a premarket notification filed by Boston Scientific with the FDA for Modification To Trelex Mesh Surgical Mesh.
| Device ID | K020110 |
| 510k Number | K020110 |
| Device Name: | MODIFICATION TO TRELEX MESH SURGICAL MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | BOSTON SCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Donna M Gardner |
| Correspondent | Donna M Gardner BOSTON SCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-11 |
| Decision Date | 2002-04-03 |
| Summary: | summary |