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FDA 510(k)

Extremely Thin 003, ZERO ZERO THREE

K-Number: K192669 · 2020-07-24

ApplicantOkamoto USA, Inc.
Decision Date2020-07-24
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Extremely Thin 003, ZERO ZERO THREE 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 2020-07-24 under 510(k) number K192669. 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 Extremely Thin 003, ZERO ZERO THREE?

Extremely Thin 003, ZERO ZERO THREE is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K192669.

When did Extremely Thin 003, ZERO ZERO THREE receive FDA 510(k) clearance?

Extremely Thin 003, ZERO ZERO THREE received FDA 510(k) clearance on 2020-07-24, under 510(k) number K192669.

Who is the listed applicant for Extremely Thin 003, ZERO ZERO THREE?

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 Extremely Thin 003, ZERO ZERO THREE?

The FDA product code for Extremely Thin 003, ZERO ZERO THREE is HIS.

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 Condom

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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