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 |