The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Restorelle L.
| Device ID | K122440 |
| 510k Number | K122440 |
| Device Name: | RESTORELLE L |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | COLOPLAST CORP. 1601 WEST RIVER RD NORTH Minneapolis, MN 55411 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree COLOPLAST CORP. 1601 WEST RIVER RD NORTH Minneapolis, MN 55411 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2012-11-19 |
| Summary: | summary |