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FDA 510(k)

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM

K-Number: K896339 · 1990-01-10

ApplicantOkamoto USA, Inc.
Decision Date1990-01-10
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 1990-01-10 under 510(k) number K896339. 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 MODIFIED LABELING ON OKAMOTO HARMONY CONDOM?

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM is a medical device that received FDA 510(k) clearance on 1990-01-10. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K896339.

When did MODIFIED LABELING ON OKAMOTO HARMONY CONDOM receive FDA 510(k) clearance?

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM received FDA 510(k) clearance on 1990-01-10, under 510(k) number K896339.

Who is the listed applicant for MODIFIED LABELING ON OKAMOTO HARMONY CONDOM?

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

What is the FDA product code for MODIFIED LABELING ON OKAMOTO HARMONY CONDOM?

The FDA product code for MODIFIED LABELING ON OKAMOTO HARMONY CONDOM is HIS.

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Other records listing Okamoto USA, 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.

K252622Male Latex Condom HAK2435840.04 ZERO ZERO FOUR Male Latex CondomK203541Okamoto 002 Lubricated Polyurethane Male CondomK192669Extremely Thin 003, ZERO ZERO THREEK090259OKAMOTO ULTRA THINK952393OKAMOTO CONDOM

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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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