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FDA 510(k)

Pre-Seed™ Fertility Lubricant

K-Number: K193450 · 2020-07-23

ApplicantChurch & Dwight Co., Inc.
Decision Date2020-07-23
Product CodePEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pre-Seed™ Fertility Lubricant is a medical device manufactured by Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2020-07-23 under approval number K193450. The device is classified under product code PEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Church & Dwight Co., Inc.. The 510(k) number is K193450.

When was Pre-Seed™ Fertility Lubricant approved by the FDA?

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

What company makes Pre-Seed™ Fertility Lubricant?

Pre-Seed™ Fertility Lubricant is manufactured by Church & Dwight Co., Inc..

What is the FDA product code for Pre-Seed™ Fertility Lubricant?

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

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Related Devices (Code: PEB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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