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FDA 510(k)

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

K-Number: K211571 · 2022-05-31

Decision Date2022-05-31
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under approval number K211571. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When was Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit approved by the FDA?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit received FDA 510(k) clearance on 2022-05-31, under approval number K211571.

What company makes Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is manufactured by Zhejiang Longterm Medical Technology Co., Ltd..

What is the FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is OMP.

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Official Source

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