The following data is part of a premarket notification filed by Uroplasty, Inc. with the FDA for Urgent Pc Neuromodulation System, Models Upc200 And Upc250-12.
| Device ID | K071822 |
| 510k Number | K071822 |
| Device Name: | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 |
| Classification | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Applicant | UROPLASTY, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Contact | Lisa Gallatin |
| Correspondent | Lisa Gallatin UROPLASTY, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Product Code | NAM |
| CFR Regulation Number | 876.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-08-20 |
| Summary: | summary |