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FDA 510(k)

EMBRACE

K-Number: K900359 · 1990-04-02

ApplicantSafetex Corp.
Decision Date1990-04-02
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EMBRACE is the device name listed in this FDA 510(k) record. The listed applicant is Safetex Corp.. It received FDA 510(k) clearance on 1990-04-02 under 510(k) number K900359. 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 EMBRACE?

EMBRACE is a medical device that received FDA 510(k) clearance on 1990-04-02. The listed applicant is Safetex Corp.. The 510(k) number is K900359.

When did EMBRACE receive FDA 510(k) clearance?

EMBRACE received FDA 510(k) clearance on 1990-04-02, under 510(k) number K900359.

Who is the listed applicant for EMBRACE?

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

What is the FDA product code for EMBRACE?

The FDA product code for EMBRACE is HIS.

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Other records listing Safetex Corp. 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.

K922889CONDOOM SHELF LIFE -- MODIFICATIONSK910550CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOWK902509SAXON RIBBED CONDOMSK900357GOLD CIRCLE COINK900360SAXON ULTRA THINK900358SAXON WET LUBE

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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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