The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Boston Scientific Surgical Mesh.
| Device ID | K081275 |
| 510k Number | K081275 |
| Device Name: | BOSTON SCIENTIFIC SURGICAL MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2008-08-27 |
| Summary: | summary |