Wellead® 橡胶导尿管
K号: K233094 · 2024-06-06
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决定日期2024-06-06
产品代码MJC
咨询委员会GU
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决定实质等同
器械摘要
Wellead® Latex Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K233094. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Wellead® Latex Foley Catheter?
Wellead® Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. The 510(k) number is K233094.
When did Wellead® Latex Foley Catheter receive FDA 510(k) clearance?
Wellead® Latex Foley Catheter received FDA 510(k) clearance on 2024-06-06, under 510(k) number K233094.
Who is the listed applicant for Wellead® Latex Foley Catheter?
The FDA 510(k) record lists Well Lead Medical (Hainan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wellead® Latex Foley Catheter?
The FDA product code for Wellead® Latex Foley Catheter is MJC.
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