Blood Bank Supplies

Supplies, Blood-bank

Fresenius Medical Care North America

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK030022
510k NumberBK030022
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Fresenius Medical Care North America 6675 185th Avenue Ne suite 100 Redmond,  WA  98052 US
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-14
Decision Date2003-07-11

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