The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus I.v. Fluid Transfer Device.
| Device ID | K080976 |
| 510k Number | K080976 |
| Device Name: | NEXUS I.V. FLUID TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Larry Smith |
| Correspondent | Larry Smith NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30892855000813 | K080976 | 000 |
| 30892855000806 | K080976 | 000 |
| 30815879021299 | K080976 | 000 |
| 30815879021008 | K080976 | 000 |
| 30815879021398 | K080976 | 000 |
| 30815879021541 | K080976 | 000 |
| 30815879021565 | K080976 | 000 |
| 30815879021664 | K080976 | 000 |