The following data is part of a premarket notification filed by Herniamesh S.r.l. with the FDA for T-sling.
| Device ID | K050516 |
| 510k Number | K050516 |
| Device Name: | T-SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | HERNIAMESH S.R.L. VIA FRATELLI MELIGA 1/C Chivasso, Torino, IT 10034 |
| Contact | Lorena Trabucco |
| Correspondent | Lorena Trabucco HERNIAMESH S.R.L. VIA FRATELLI MELIGA 1/C Chivasso, Torino, IT 10034 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() T-SLING 88437587 5920745 Live/Registered |
Troy Industries, Inc. 2019-05-20 |
![]() T-SLING 79029642 3749874 Dead/Cancelled |
HERNIAMESH S.R.L. 2006-09-19 |
![]() T-SLING 78522173 3303515 Dead/Cancelled |
HERNIAMESH S.R.L. 2004-11-23 |