The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Bioarc Sp Sling Kit And Bioarc To Sling Kit, Models 72403851, 72403996.
| Device ID | K040538 |
| 510k Number | K040538 |
| Device Name: | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Denise Thompson |
| Correspondent | Denise Thompson AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-03-17 |
| Summary: | summary |