FDA 510(k)

特洛伊链式反应天然乳胶安全套，带感觉润滑剂

K号: K180104 · 2018-03-14

决定日期2018-03-14

产品代码HIS

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

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K180104. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant?

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K180104.

When did Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant receive FDA 510(k) clearance?

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant received FDA 510(k) clearance on 2018-03-14, under 510(k) number K180104.

Who is the listed applicant for Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant?

The FDA product code for Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is HIS.

列明Church & Dwight Co., Inc.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。

K243640特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）K240379TROJAN SIS 合成乳胶避孕套带硅润滑剂 K221906TROJAN 火与冰润滑男性天然橡胶乳胶避孕套 K221431TROJAN™ 她的愉悦保暖男性天然橡胶乳胶避孕套带保暖润滑剂 K203818Replens长效阴道保湿剂 K193450Pre-Seed®生育润滑剂

查看所有 12 个设备 →

相关器械（代码：HIS）

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。

K262108FAMA男性乳胶避孕套 - 水性润滑剂（超薄型）；FAMA男性乳胶避孕套 - 水性润滑剂（普通型）；FAMA男性乳胶避孕套 - 水性润滑剂（肋纹型）；FAMA男性乳胶避孕套 - 水性润滑剂（点状型）；FAMA男性乳胶避孕套 - 水性润滑剂（非规则形状型）；MO男性乳胶避孕套 - 水性润滑剂（超薄型）；MO男性乳胶避孕套 - 水性润滑剂（普通型）；MO男性乳胶避孕套 - 水性润滑剂（肋纹型）；MO男性乳胶避孕套 - 水性润滑剂（点状型）；MOShanghai Personage Hygiene Products Co., Ltd.K252622男性乳胶避孕套HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel天然橡胶乳胶避孕套Suretex Limited K250034天然橡胶乳胶男用避孕套Shaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex 润滑天然乳胶安全套Lelo, Inc.K243640特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）Church & Dwight Co., Inc.

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。