Cohitech可重复使用棉塞推杆
K号: K212479 · 2021-10-08
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决定日期2021-10-08
产品代码HEB
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Cohitech Reusable Tampon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Cotton High Tech S.L.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K212479. 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 Cohitech Reusable Tampon Applicator?
Cohitech Reusable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K212479.
When did Cohitech Reusable Tampon Applicator receive FDA 510(k) clearance?
Cohitech Reusable Tampon Applicator received FDA 510(k) clearance on 2021-10-08, under 510(k) number K212479.
Who is the listed applicant for Cohitech Reusable Tampon Applicator?
The FDA 510(k) record lists Cotton High Tech S.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cohitech Reusable Tampon Applicator?
The FDA product code for Cohitech Reusable Tampon Applicator 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。
列明Cotton High Tech S.L.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。
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。
K252005Livi 设备Liviwell, Inc.K253719无香月经长型推杆卫生巾；无香月经纸盒推杆卫生巾；无香月经数字卫生巾Unibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613无香型三件套月经棒Unibeauty (Hubei) Technology Co., Ltd.K251033无香型月经长型棒状卫生棉条；无香型月经紧凑型棒状卫生棉条；无香型月经纸盒型棒状卫生棉条；无香型月经数字型卫生棉条Unibeauty (Hubei) Technology Co., Ltd.K242105SABA 棉签Essity Higiene Y Salud Mexico. S.A. DE C.V.
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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