The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Injection Site (nis), Model Nis-1.
| Device ID | K024363 |
| 510k Number | K024363 |
| Device Name: | NEXUS INJECTION SITE (NIS), MODEL NIS-1 |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL, LLC 11428 LOSTWOOD LN. SUITE B Raleigh, NC 27614 |
| Contact | Jamie Abourched |
| Correspondent | Jamie Abourched NEXUS MEDICAL, LLC 11428 LOSTWOOD LN. SUITE B Raleigh, NC 27614 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-31 |
| Decision Date | 2003-02-19 |