FDA 510(k)

Pre-Seed®生育润滑剂

K号: K193450 · 2020-07-23

决定日期2020-07-23

产品代码PEB

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决定实质等同

器械摘要

Pre-Seed™ Fertility 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 2020-07-23 under 510(k) number K193450. The device is classified under product code PEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pre-Seed™ Fertility Lubricant?

Pre-Seed™ Fertility Lubricant is a medical device that received FDA 510(k) clearance on 2020-07-23. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K193450.

When did Pre-Seed™ Fertility Lubricant receive FDA 510(k) clearance?

Pre-Seed™ Fertility Lubricant received FDA 510(k) clearance on 2020-07-23, under 510(k) number K193450.

Who is the listed applicant for Pre-Seed™ Fertility 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 Pre-Seed™ Fertility Lubricant?

The FDA product code for Pre-Seed™ Fertility Lubricant is PEB.

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 K180764特洛伊TM 阿祖尔个人润滑剂（H2O敏感触感个人润滑剂）

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官方来源

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