FDA 510(k)

特洛伊TM 阿祖尔个人润滑剂（H2O敏感触感个人润滑剂）

K号: K180764 · 2018-08-01

决定日期2018-08-01

产品代码NUC

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决定实质等同

器械摘要

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal 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 2018-08-01 under 510(k) number K180764. 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 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K180764.

When did TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) receive FDA 510(k) clearance?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180764.

Who is the listed applicant for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal 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 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

The FDA product code for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) 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 K203818Replens长效阴道保湿剂 K193450Pre-Seed®生育润滑剂

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官方来源

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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。