The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Align And Align To Urethral Support Systems.
| Device ID | K093747 |
| 510k Number | K093747 |
| Device Name: | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | John Knorpp |
| Correspondent | John Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-05-07 |
| Summary: | summary |