The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Injection Site, Model Nis-8.
| Device ID | K092527 |
| 510k Number | K092527 |
| Device Name: | NEXUS INJECTION SITE, MODEL NIS-8 |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Heather Turner |
| Correspondent | Heather Turner NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-18 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30892855000875 | K092527 | 000 |
| 30892855000714 | K092527 | 000 |