The following data is part of a premarket notification filed by Advanced Uro-solutions, Inc. with the FDA for Nuro Neuromodulation System.
| Device ID | K132561 |
| 510k Number | K132561 |
| Device Name: | NURO NEUROMODULATION SYSTEM |
| Classification | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Applicant | ADVANCED URO-SOLUTIONS, INC. 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt ADVANCED URO-SOLUTIONS, INC. 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Product Code | NAM |
| CFR Regulation Number | 876.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2013-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169654631 | K132561 | 000 |
| 00643169654624 | K132561 | 000 |
| 00763000157487 | K132561 | 000 |