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FDA 510(k)

DUREX COLORS AND SCENTS

K-Number: K980174 · 1998-08-13

ApplicantLondon Intl., LLC
Decision Date1998-08-13
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUREX COLORS AND SCENTS is the device name listed in this FDA 510(k) record. The listed applicant is London Intl., LLC. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K980174. 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 DUREX COLORS AND SCENTS?

DUREX COLORS AND SCENTS is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is London Intl., LLC. The 510(k) number is K980174.

When did DUREX COLORS AND SCENTS receive FDA 510(k) clearance?

DUREX COLORS AND SCENTS received FDA 510(k) clearance on 1998-08-13, under 510(k) number K980174.

Who is the listed applicant for DUREX COLORS AND SCENTS?

The FDA 510(k) record lists London Intl., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUREX COLORS AND SCENTS?

The FDA product code for DUREX COLORS AND SCENTS is HIS.

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Other records listing London Intl., LLC 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.

K982924DUREX SENSIDOM LATEX CONDOMK983380DUREX LUBRAGEL LATEX CONDOMK980785STERILE, POWDERFREE LATEX EXAMINATION GLOVEK980319DUREX ULTRA COMFORTK980204DUREX LATEX CONDOMS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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