Exemption number: e2016018.B.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number 400424833.This follow up report is being filed to correct the branding, product code, and 510(k) information that was entered on the initial mdr in this report.This report was filed for item number, 4253566-01, which is not sold in the united states, however a similar item number, 4253566-02, is sold in the united states by b.Braun medical, inc.The 510(k) has been updated to reflect a 510(k) that item 4253566-02 has been cleared under.Note: b.Braun is aware that the listed exemption has been withdrawn, however since the initial mdr report was filed under this exemption, the follow up is also being filed under the exemption.
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