The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Bvi Sling.
| Device ID | K002233 |
| 510k Number | K002233 |
| Device Name: | BVI SLING |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Daisy P Sin |
| Correspondent | Daisy P Sin BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-10-13 |