FDA 510(k)

TOSAMA 可重复使用敷料器

K号: K232060 · 2024-04-12

决定日期2024-04-12

产品代码HEB

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决定实质等同

器械摘要

TOSAMA Reusable Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Tosama, D.O.O.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232060. 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 TOSAMA Reusable Applicator?

TOSAMA Reusable Applicator is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Tosama, D.O.O.. The 510(k) number is K232060.

When did TOSAMA Reusable Applicator receive FDA 510(k) clearance?

TOSAMA Reusable Applicator received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232060.

Who is the listed applicant for TOSAMA Reusable Applicator?

The FDA 510(k) record lists Tosama, D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOSAMA Reusable Applicator?

The FDA product code for TOSAMA Reusable Applicator is HEB.

列明Tosama, D.O.O.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。

K172504托萨玛生物基应用管月经棉条

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

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