Transfer Sets

Set, Transfer (blood/plasma)

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 Transfer Sets.

Pre-market Notification Details

Device IDBK040076
510k NumberBK040076
Device Name:Transfer Sets
ClassificationSet, Transfer (blood/plasma)
Applicant Fresenius Medical Care North America 95 Hayden Avenue Lexington,  MA  02420 US
Product CodeKSB  
CFR Regulation Number864.9875 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-13
Decision Date2004-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000860215 BK040076 0

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