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FDA 510(k)

bibag

K-Number: K162716 · 2017-05-18

Decision Date2017-05-18
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

bibag is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2017-05-18 under approval number K162716. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the bibag?

bibag is a medical device that received FDA 510(k) clearance on 2017-05-18. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K162716.

When was bibag approved by the FDA?

bibag received FDA 510(k) clearance on 2017-05-18, under approval number K162716.

What company makes bibag?

bibag is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for bibag?

The FDA product code for bibag is KPO.

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.