FDA 510(k)

LELO RESPECT HEX 天然橡胶乳胶避孕套

K号: K162511 · 2017-01-13

决定日期2017-01-13

产品代码HIS

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决定实质等同

器械摘要

LELO RESPECT HEX Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Lelo, Inc.. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K162511. 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 LELO RESPECT HEX Natural Rubber Latex Condom?

LELO RESPECT HEX Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Lelo, Inc.. The 510(k) number is K162511.

When did LELO RESPECT HEX Natural Rubber Latex Condom receive FDA 510(k) clearance?

LELO RESPECT HEX Natural Rubber Latex Condom received FDA 510(k) clearance on 2017-01-13, under 510(k) number K162511.

Who is the listed applicant for LELO RESPECT HEX Natural Rubber Latex Condom?

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

What is the FDA product code for LELO RESPECT HEX Natural Rubber Latex Condom?

The FDA product code for LELO RESPECT HEX Natural Rubber Latex Condom is HIS.

列明Lelo, 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。

K243421Lelo Hex 润滑天然乳胶安全套 K160644Lelo Hex 天然乳胶安全套

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

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