FDA 510(k)

Replens长效阴道保湿剂

K号: K203818 · 2021-06-11

决定日期2021-06-11

产品代码NUC

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决定实质等同

器械摘要

Replens Long-Lasting Vaginal Moisturizer 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 2021-06-11 under 510(k) number K203818. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Replens Long-Lasting Vaginal Moisturizer?

Replens Long-Lasting Vaginal Moisturizer is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K203818.

When did Replens Long-Lasting Vaginal Moisturizer receive FDA 510(k) clearance?

Replens Long-Lasting Vaginal Moisturizer received FDA 510(k) clearance on 2021-06-11, under 510(k) number K203818.

Who is the listed applicant for Replens Long-Lasting Vaginal Moisturizer?

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 Replens Long-Lasting Vaginal Moisturizer?

The FDA product code for Replens Long-Lasting Vaginal Moisturizer is NUC.

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 K193450Pre-Seed®生育润滑剂 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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