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 |