The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Triangle Sling.
| Device ID | K980482 |
| 510k Number | K980482 |
| Device Name: | TRIANGLE SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | INFLUENCE, INC. 11812 QUINCE MILL DR. North Potomac, MD 20878 |
| Contact | Mark D Kramer |
| Correspondent | Mark D Kramer INFLUENCE, INC. 11812 QUINCE MILL DR. North Potomac, MD 20878 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-03-27 |
| Summary: | summary |