The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc with the FDA for Amicus Separator System, Amicus Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter.
Device ID | K180615 |
510k Number | K180615 |
Device Name: | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich, IL 60047 |
Contact | Kim Forch |
Correspondent | Kim Forch Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich, IL 60047 |
Product Code | LKN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-08 |
Decision Date | 2018-12-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04086000101950 | K180615 | 000 |
04052682031724 | K180615 | 000 |