The following data is part of a premarket notification filed by Neomedic International with the FDA for Surelift Prolapse System.
| Device ID | K102815 |
| 510k Number | K102815 |
| Device Name: | SURELIFT PROLAPSE SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | NEOMEDIC INTERNATIONAL 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman NEOMEDIC INTERNATIONAL 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2011-07-07 |
| Summary: | summary |