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FDA 510(k)

KIMONO MICROTHIN

K-Number: K946374 · 1995-11-08

ApplicantMayer Laboratories
Decision Date1995-11-08
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KIMONO MICROTHIN is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K946374. 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?

KIMONO MICROTHIN is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Mayer Laboratories. The 510(k) number is K946374.

When did KIMONO MICROTHIN receive FDA 510(k) clearance?

KIMONO MICROTHIN received FDA 510(k) clearance on 1995-11-08, under 510(k) number K946374.

Who is the listed applicant for KIMONO MICROTHIN?

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

What is the FDA product code for KIMONO MICROTHIN?

The FDA product code for KIMONO MICROTHIN is HIS.

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Other records listing Mayer Laboratories 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.

K252158Sagami Original 002 Polyurethane Male CondomK001974EZ-ON CONDOMK946376MAXXK943064KIMONO (CONDOMS)K925869SHEATHES, STERILE SHEATHESK926049DIGITEX, DIGITEX HYPOALLERGENIC

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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.

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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