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FDA 510(k)

CONDOM (RUBBER) CONTRACEPTIVE

K-Number: K901416 · 1990-06-04

ApplicantAladan Corp.
Decision Date1990-06-04
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONDOM (RUBBER) CONTRACEPTIVE is the device name listed in this FDA 510(k) record. The listed applicant is Aladan Corp.. It received FDA 510(k) clearance on 1990-06-04 under 510(k) number K901416. 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 CONDOM (RUBBER) CONTRACEPTIVE?

CONDOM (RUBBER) CONTRACEPTIVE is a medical device that received FDA 510(k) clearance on 1990-06-04. The listed applicant is Aladan Corp.. The 510(k) number is K901416.

When did CONDOM (RUBBER) CONTRACEPTIVE receive FDA 510(k) clearance?

CONDOM (RUBBER) CONTRACEPTIVE received FDA 510(k) clearance on 1990-06-04, under 510(k) number K901416.

Who is the listed applicant for CONDOM (RUBBER) CONTRACEPTIVE?

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

What is the FDA product code for CONDOM (RUBBER) CONTRACEPTIVE?

The FDA product code for CONDOM (RUBBER) CONTRACEPTIVE is HIS.

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Other records listing Aladan Corp. as applicant

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Related Devices (Code: HIS)

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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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