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FDA 510(k)

UNDUS MALE LATEX CONDOM (WITH FLAVORING)

K-Number: K023176 · 2002-12-13

ApplicantUnidus Corp.
Decision Date2002-12-13
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UNDUS MALE LATEX CONDOM (WITH FLAVORING) is the device name listed in this FDA 510(k) record. The listed applicant is Unidus Corp.. It received FDA 510(k) clearance on 2002-12-13 under 510(k) number K023176. 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 UNDUS MALE LATEX CONDOM (WITH FLAVORING)?

UNDUS MALE LATEX CONDOM (WITH FLAVORING) is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Unidus Corp.. The 510(k) number is K023176.

When did UNDUS MALE LATEX CONDOM (WITH FLAVORING) receive FDA 510(k) clearance?

UNDUS MALE LATEX CONDOM (WITH FLAVORING) received FDA 510(k) clearance on 2002-12-13, under 510(k) number K023176.

Who is the listed applicant for UNDUS MALE LATEX CONDOM (WITH FLAVORING)?

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

What is the FDA product code for UNDUS MALE LATEX CONDOM (WITH FLAVORING)?

The FDA product code for UNDUS MALE LATEX CONDOM (WITH FLAVORING) is HIS.

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Other records listing Unidus 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.

K072747UNIDUS MAGNUM MALE LATEX CONDOMK033541LONG LOVE CONDOMK023129UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)K023175UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)K023059UNIDUS MALE LATEX CONDOMK891854SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX)

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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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