The following data is part of a premarket notification filed by Advanced Uroscience, Inc. with the FDA for Advanced Uroscience Injection Needle.
| Device ID | K002323 |
| 510k Number | K002323 |
| Device Name: | ADVANCED UROSCIENCE INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2000-07-31 |