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FDA 510(k)

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant

K-Number: K180104 · 2018-03-14

ApplicantChurch & Dwight Co., Inc.
Decision Date2018-03-14
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate 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 2018-03-14 under 510(k) number K180104. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant?

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K180104.

When did Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant receive FDA 510(k) clearance?

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant received FDA 510(k) clearance on 2018-03-14, under 510(k) number K180104.

Who is the listed applicant for Trojan Chain Reaction Natural Rubber Latex Condom with Sensate 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 Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant?

The FDA product code for Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is HIS.

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Other records listing Church & Dwight Co., Inc. as applicant

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Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.

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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