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 |