The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Irrigation Tubing Set.
| Device ID | K062551 |
| 510k Number | K062551 |
| Device Name: | NEXUS IRRIGATION TUBING SET |
| Classification | System, Irrigation, Urological |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Anita Smith |
| Correspondent | Anita Smith NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2006-12-15 |