The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Align Urethral Support System.
| Device ID | K070073 |
| 510k Number | K070073 |
| Device Name: | ALIGN URETHRAL SUPPORT SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Contact | Julie J Bassett |
| Correspondent | Julie J Bassett C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-08 |
| Decision Date | 2007-03-21 |
| Summary: | summary |