The following data is part of a premarket notification filed by Uroplasty, Inc. with the FDA for Urgent Pc Neuromodulation System, Models Upc200-a And Upc250-12.
| Device ID | K061333 |
| 510k Number | K061333 |
| Device Name: | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 |
| Classification | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Applicant | UROPLASTY, INC. 2718 SUMMER ST. NE Minneapolis, MN 55413 -2820 |
| Contact | Lisa Gallatin |
| Correspondent | Lisa Gallatin UROPLASTY, INC. 2718 SUMMER ST. NE Minneapolis, MN 55413 -2820 |
| Product Code | NAM |
| CFR Regulation Number | 876.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-12 |
| Decision Date | 2006-07-03 |
| Summary: | summary |