FDA 510(k)

BioGenesis 生育润滑剂

K号: K190872 · 2019-11-07

决定日期2019-11-07

产品代码PEB

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决定实质等同

器械摘要

BioGenesis Fertility Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Good Clean Love, Inc.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K190872. 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 BioGenesis Fertility Lubricant?

BioGenesis Fertility Lubricant is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Good Clean Love, Inc.. The 510(k) number is K190872.

When did BioGenesis Fertility Lubricant receive FDA 510(k) clearance?

BioGenesis Fertility Lubricant received FDA 510(k) clearance on 2019-11-07, under 510(k) number K190872.

Who is the listed applicant for BioGenesis Fertility Lubricant?

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

What is the FDA product code for BioGenesis Fertility Lubricant?

The FDA product code for BioGenesis Fertility Lubricant is PEB.

列明Good Clean Love, 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。

K242162椰子混合型 K212000Medley K211998Desnuda Reflect K193448BioNourish 润滑剂 K180136BioNude 润滑剂

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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。