The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Bonee Needle For Bladder Injections, Modelsnbi035, Nbi070.
| Device ID | K090217 |
| 510k Number | K090217 |
| Device Name: | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Contact | Suresh Ghal |
| Correspondent | Suresh Ghal COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-29 |
| Decision Date | 2009-04-23 |
| Summary: | summary |