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FDA 510(k)

SUMMER'S EVE LUBRICATING JELLY

K-Number: K990597 · 1999-07-19

ApplicantC.B. Fleet Co., Inc.
Decision Date1999-07-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SUMMER'S EVE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is C.B. Fleet Co., Inc.. It received FDA 510(k) clearance on 1999-07-19 under 510(k) number K990597. 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 SUMMER'S EVE LUBRICATING JELLY?

SUMMER'S EVE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 1999-07-19. The listed applicant is C.B. Fleet Co., Inc.. The 510(k) number is K990597.

When did SUMMER'S EVE LUBRICATING JELLY receive FDA 510(k) clearance?

SUMMER'S EVE LUBRICATING JELLY received FDA 510(k) clearance on 1999-07-19, under 510(k) number K990597.

Who is the listed applicant for SUMMER'S EVE LUBRICATING JELLY?

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

What is the FDA product code for SUMMER'S EVE LUBRICATING JELLY?

The FDA product code for SUMMER'S EVE LUBRICATING JELLY is HIS.

Related Clinical Trials

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.

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Other records listing C.B. Fleet Co., 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.

K812728FLEET DETECTATEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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