The following data is part of a premarket notification filed by Mpathy Medical Devices, Ltd. with the FDA for Modification To: Minimesh Polypropylene Mesh.
| Device ID | K053361 |
| 510k Number | K053361 |
| Device Name: | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | MPATHY MEDICAL DEVICES, LTD. 150 ARAN HILL ROAD Fairfield, CT 06824 -1712 |
| Contact | Louis J Mazzarese |
| Correspondent | Louis J Mazzarese MPATHY MEDICAL DEVICES, LTD. 150 ARAN HILL ROAD Fairfield, CT 06824 -1712 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-02-06 |
| Summary: | summary |