The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Pav Luer Lock Device, Model Nis-4.
Device ID | K041845 |
510k Number | K041845 |
Device Name: | NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 |
Classification | Set, Administration, Intravascular |
Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
Contact | Al Boedeker |
Correspondent | Al Boedeker NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-08 |
Decision Date | 2004-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30892855000011 | K041845 | 000 |