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FDA 510(k)

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

K号: K252939 · 2025-10-09

申请人Cotton High Tech S.L.
决定日期2025-10-09
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 ORGANIC COTTON COMPACT APPLICATOR TAMPONS 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 2025-10-09 under 510(k) number K252939. 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 ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K252939.

When did COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS receive FDA 510(k) clearance?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252939.

Who is the listed applicant for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

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 ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

The FDA product code for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K220238Cohitech Cottonlock棉塞带可重复使用推杆K211775Cohitech有机棉非推杆Cottonlock棉塞K212479Cohitech可重复使用棉塞推杆K182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

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.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.K241064无香卫生巾Shandong Intco Hygiene Products Co., Ltd.

官方来源

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