FDA 510(k)

小型泡沫套件，中型泡沫套件，大型泡沫套件，超大型泡沫套件

K号: K211571 · 2022-05-31

申请人Zhejiang Longterm Medical Technology Co., Ltd.

决定日期2022-05-31

产品代码OMP

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When did Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

FDA 510(k)记录将浙江龙泰医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Zhejiang Longterm Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254246LT银离子抗菌泡沫敷料 K202823Innomed NPWT 硅胶泡沫敷料 K192478LT 银抗菌藻酸盐敷料 K182458Longterm NPWT泡沫敷料套装

官方来源

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