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 |