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FDA 510(k)

NUDA (CURRENTLY CALLED ULTRA SENSITIVE)

K-Number: K901111 · 1990-03-27

ApplicantAnsell, Inc.
Decision Date1990-03-27
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NUDA (CURRENTLY CALLED ULTRA SENSITIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1990-03-27 under 510(k) number K901111. 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 NUDA (CURRENTLY CALLED ULTRA SENSITIVE)?

NUDA (CURRENTLY CALLED ULTRA SENSITIVE) is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Ansell, Inc.. The 510(k) number is K901111.

When did NUDA (CURRENTLY CALLED ULTRA SENSITIVE) receive FDA 510(k) clearance?

NUDA (CURRENTLY CALLED ULTRA SENSITIVE) received FDA 510(k) clearance on 1990-03-27, under 510(k) number K901111.

Who is the listed applicant for NUDA (CURRENTLY CALLED ULTRA SENSITIVE)?

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

What is the FDA product code for NUDA (CURRENTLY CALLED ULTRA SENSITIVE)?

The FDA product code for NUDA (CURRENTLY CALLED ULTRA SENSITIVE) is HIS.

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Other records listing Ansell, Inc. as applicant

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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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