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FDA 510(k)

K-Y PERSONAL LUBRICANT

K-Number: K955648 · 1996-06-21

ApplicantOrtho Pharmaceutical Corp.
Decision Date1996-06-21
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

K-Y PERSONAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pharmaceutical Corp.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K955648. 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 K-Y PERSONAL LUBRICANT?

K-Y PERSONAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Ortho Pharmaceutical Corp.. The 510(k) number is K955648.

When did K-Y PERSONAL LUBRICANT receive FDA 510(k) clearance?

K-Y PERSONAL LUBRICANT received FDA 510(k) clearance on 1996-06-21, under 510(k) number K955648.

Who is the listed applicant for K-Y PERSONAL LUBRICANT?

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

What is the FDA product code for K-Y PERSONAL LUBRICANT?

The FDA product code for K-Y PERSONAL LUBRICANT is HIS.

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Other records listing Ortho Pharmaceutical Corp. 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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