FDA 510(k)

Bio-MEM Ti Reinforced Membrane

K-Number: K210797 · 2022-08-18

Decision Date2022-08-18

Product CodeNPK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Bio-MEM Ti Reinforced Membrane is a medical device manufactured by B&Medi Co., Ltd.. It received FDA 510(k) clearance on 2022-08-18 under approval number K210797. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio-MEM Ti Reinforced Membrane?

Bio-MEM Ti Reinforced Membrane is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by B&Medi Co., Ltd.. The 510(k) number is K210797.

When was Bio-MEM Ti Reinforced Membrane approved by the FDA?

Bio-MEM Ti Reinforced Membrane received FDA 510(k) clearance on 2022-08-18, under approval number K210797.

What company makes Bio-MEM Ti Reinforced Membrane?

Bio-MEM Ti Reinforced Membrane is manufactured by B&Medi Co., Ltd..

What is the FDA product code for Bio-MEM Ti Reinforced Membrane?

The FDA product code for Bio-MEM Ti Reinforced Membrane is NPK.

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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.