The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Alyte Y-mesh Graft.
| Device ID | K101722 |
| 510k Number | K101722 |
| Device Name: | ALYTE Y-MESH GRAFT |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Scott Robirds |
| Correspondent | Scott Robirds C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2011-04-01 |
| Summary: | summary |