The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Blue Sui Sling.
| Device ID | K121754 |
| 510k Number | K121754 |
| Device Name: | BLUE SUI SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY M21 Marlborough, MA 01752 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY M21 Marlborough, MA 01752 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-14 |
| Decision Date | 2012-10-10 |
| Summary: | summary |