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FDA 510(k)

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED

K-Number: K113686 · 2012-03-06

ApplicantMayer Laboratories, Inc.
Decision Date2012-03-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories, Inc.. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K113686. 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 KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED?

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Mayer Laboratories, Inc.. The 510(k) number is K113686.

When did KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED receive FDA 510(k) clearance?

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED received FDA 510(k) clearance on 2012-03-06, under 510(k) number K113686.

Who is the listed applicant for KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED?

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

What is the FDA product code for KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED?

The FDA product code for KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED is HIS.

Related Clinical Trials

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.

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Other records listing Mayer Laboratories, Inc. as applicant

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.

K130345AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMINGK110325AQUA LUBE

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.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.

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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