The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Exair Anterior And Posterior Prolapse Repair Systems.
| Device ID | K083499 |
| 510k Number | K083499 |
| Device Name: | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | COLOPLAST A/S 1499 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley COLOPLAST A/S 1499 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-05-08 |
| Summary: | summary |