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FDA 510(k)

DIVAS DUAL PLEASURE MALE LATEX CONDOM

K-Number: K051273 · 2005-08-19

ApplicantEagle Twe, Inc.
Decision Date2005-08-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DIVAS DUAL PLEASURE MALE LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Twe, Inc.. It received FDA 510(k) clearance on 2005-08-19 under 510(k) number K051273. 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 DIVAS DUAL PLEASURE MALE LATEX CONDOM?

DIVAS DUAL PLEASURE MALE LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2005-08-19. The listed applicant is Eagle Twe, Inc.. The 510(k) number is K051273.

When did DIVAS DUAL PLEASURE MALE LATEX CONDOM receive FDA 510(k) clearance?

DIVAS DUAL PLEASURE MALE LATEX CONDOM received FDA 510(k) clearance on 2005-08-19, under 510(k) number K051273.

Who is the listed applicant for DIVAS DUAL PLEASURE MALE LATEX CONDOM?

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

What is the FDA product code for DIVAS DUAL PLEASURE MALE LATEX CONDOM?

The FDA product code for DIVAS DUAL PLEASURE MALE LATEX CONDOM is HIS.

Related Clinical Trials

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Other records listing Eagle Twe, 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.

K010028SHEER THIN AROMAS RED LATEX CONDOMK004051SHEER THIN AROMAS YELLOW LATEX CONDOMK004036SHEER THIN AROMAS GREEN LATEX CONDOMK004016SHEER THIN AROMAS BLUE LATEX 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.

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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