The following data is part of a premarket notification filed by Herniamesh with the FDA for Herniamesh T-sling.
| Device ID | K020652 |
| 510k Number | K020652 |
| Device Name: | HERNIAMESH T-SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | HERNIAMESH 8 ORANGE DR. Jericho, NY 11753 |
| Contact | Lorena Trabucco |
| Correspondent | Lorena Trabucco HERNIAMESH 8 ORANGE DR. Jericho, NY 11753 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-28 |
| Decision Date | 2002-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28032919892120 | K020652 | 000 |