FDA 510(k)

特洛伊超润滑聚氨酯男性避孕套

K号: K171639 · 2017-08-01

决定日期2017-08-01

产品代码MOL

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决定实质等同

器械摘要

Trojan Supra Lubricated Polyurethane Male Condom 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 2017-08-01 under 510(k) number K171639. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trojan Supra Lubricated Polyurethane Male Condom?

Trojan Supra Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K171639.

When did Trojan Supra Lubricated Polyurethane Male Condom receive FDA 510(k) clearance?

Trojan Supra Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171639.

Who is the listed applicant for Trojan Supra Lubricated Polyurethane Male Condom?

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 Supra Lubricated Polyurethane Male Condom?

The FDA product code for Trojan Supra Lubricated Polyurethane Male Condom is MOL.

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。