FEMME施用器棉塞
K号: K182142 · 2019-08-28
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决定日期2019-08-28
产品代码HEB
咨询委员会OB
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决定实质等同
器械摘要
FEMME Applicator Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yoai Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K182142. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FEMME Applicator Tampon?
FEMME Applicator Tampon is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Jiangsu Yoai Technology Co., Ltd.. The 510(k) number is K182142.
When did FEMME Applicator Tampon receive FDA 510(k) clearance?
FEMME Applicator Tampon received FDA 510(k) clearance on 2019-08-28, under 510(k) number K182142.
Who is the listed applicant for FEMME Applicator Tampon?
The FDA 510(k) record lists Jiangsu Yoai Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FEMME Applicator Tampon?
The FDA product code for FEMME Applicator Tampon is HEB.
相关临床试验
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。
相关器械（代码：HEB）
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。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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