FDA 510(k)

Ontex和其他专有名称

K号: K162746 · 2017-03-03

决定日期2017-03-03

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

Ontex and other proprietary names is the device name listed in this FDA 510(k) record. The listed applicant is Ontex Bvba. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162746. 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 Ontex and other proprietary names?

Ontex and other proprietary names is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Ontex Bvba. The 510(k) number is K162746.

When did Ontex and other proprietary names receive FDA 510(k) clearance?

Ontex and other proprietary names received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162746.

Who is the listed applicant for Ontex and other proprietary names?

The FDA 510(k) record lists Ontex Bvba as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ontex and other proprietary names?

The FDA product code for Ontex and other proprietary names is HEB.

列明Ontex Bvba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。

K191666无香W型长塑料和纸制棒状卫生棉条

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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