The following data is part of a premarket notification filed by Specialities Remeex International, S.l. with the FDA for Remeex System For Urinary Incontinence.
| Device ID | K033310 |
| 510k Number | K033310 |
| Device Name: | REMEEX SYSTEM FOR URINARY INCONTINENCE |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | SPECIALITIES REMEEX INTERNATIONAL, S.L. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman SPECIALITIES REMEEX INTERNATIONAL, S.L. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-01-15 |
| Summary: | summary |