The following data is part of a premarket notification filed by Mpathy Medical Devices Inc with the FDA for Restorelle Polypropylene Mesh.
| Device ID | K092207 |
| 510k Number | K092207 |
| Device Name: | RESTORELLE POLYPROPYLENE MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | MPATHY MEDICAL DEVICES INC 208 WRIGHT BUSINESS CENTRE LONMAY ROAD Glasgow, GB G33-4el |
| Contact | Caroline Stretton |
| Correspondent | Caroline Stretton MPATHY MEDICAL DEVICES INC 208 WRIGHT BUSINESS CENTRE LONMAY ROAD Glasgow, GB G33-4el |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-08-04 |
| Summary: | summary |