The following data is part of a premarket notification filed by Influence, Inc. with the FDA for In-sling.
| Device ID | K972651 |
| 510k Number | K972651 |
| Device Name: | IN-SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-09-19 |
| Summary: | summary |