Empty Containers For The Collection & Processing Of Blood/Blood Components

Container, Empty, For Collection & Processing Of Blood & Blood Components

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.

Pre-market Notification Details

Device IDBK190362
510k NumberBK190362
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Fresenius Kabi AG three Corporate Dr Lake Zurich,  IL  60047 US
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-24
Decision Date2019-07-19

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