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FDA 510(k)

TACTYLON(TM) CONDOM

K-Number: K911431 · 1994-12-27

ApplicantTactyl Technologies, Inc.
Decision Date1994-12-27
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TACTYLON(TM) CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Tactyl Technologies, Inc.. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K911431. 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 TACTYLON(TM) CONDOM?

TACTYLON(TM) CONDOM is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Tactyl Technologies, Inc.. The 510(k) number is K911431.

When did TACTYLON(TM) CONDOM receive FDA 510(k) clearance?

TACTYLON(TM) CONDOM received FDA 510(k) clearance on 1994-12-27, under 510(k) number K911431.

Who is the listed applicant for TACTYLON(TM) CONDOM?

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

What is the FDA product code for TACTYLON(TM) CONDOM?

The FDA product code for TACTYLON(TM) CONDOM is HIS.

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Other records listing Tactyl Technologies, 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.

K955464TACTYLON POWDER FREE EXAMINATION GLOVEK955419POWDER FREE TACTYLON SURGEONS GLOVEK953583LUBRICATED CONDOMK950185TACTYLON(TM) POWDER FREE SURGEONS GLOVEK905109PATIENT EXAMINATION GLOVE/HYPOALLERGENICK902831TACTYLON TM SURGICAL GLOVE

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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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