The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Pelvilace Transobturator Biourethral Support System (pelvilace To System).
| Device ID | K042949 |
| 510k Number | K042949 |
| Device Name: | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | John C Knorpp |
| Correspondent | John C Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | PAG |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-26 |
| Decision Date | 2004-11-09 |
| Summary: | summary |