The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Exair Anterior And Posterior Prolapse Repair System.
| Device ID | K112386 |
| 510k Number | K112386 |
| Device Name: | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | COLOPLAST CORP. 1601 WEST RIVER N Minneapolis, MN 55411 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree COLOPLAST CORP. 1601 WEST RIVER N Minneapolis, MN 55411 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2011-09-08 |
| Summary: | summary |