The following data is part of a premarket notification filed by Mpathy Medical Devices, Ltd. with the FDA for Minitape Urethral Sling.
| Device ID | K073646 |
| 510k Number | K073646 |
| Device Name: | MINITAPE URETHRAL SLING |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison, CT 06443 |
| Contact | Louis J Mazzarese |
| Correspondent | Louis J Mazzarese MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison, CT 06443 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-02-25 |
| Summary: | summary |