FDA 510(k)

尤佳无香卫生棉条，配备塑料推杆

K号: K192557 · 2020-02-13

申请人Qingdao Youjia Hygiene Technology Co., Ltd.

决定日期2020-02-13

产品代码HEB

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决定实质等同

器械摘要

Youjia Unscented Tampon with Plastic Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192557. 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 Youjia Unscented Tampon with Plastic Applicators?

Youjia Unscented Tampon with Plastic Applicators is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. The 510(k) number is K192557.

When did Youjia Unscented Tampon with Plastic Applicators receive FDA 510(k) clearance?

Youjia Unscented Tampon with Plastic Applicators received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192557.

Who is the listed applicant for Youjia Unscented Tampon with Plastic Applicators?

The FDA 510(k) record lists Qingdao Youjia Hygiene Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Youjia Unscented Tampon with Plastic Applicators?

The FDA product code for Youjia Unscented Tampon with Plastic Applicators is HEB.

列明Qingdao Youjia Hygiene Technology Co., Ltd.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。

K190218无香卫生巾

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.

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