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FDA 510(k)

GEL FILLED GUM SOOTHER

K-Number: K092494 · 2010-03-01

ApplicantLuv N' Care, Ltd.
Decision Date2010-03-01
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEL FILLED GUM SOOTHER is the device name listed in this FDA 510(k) record. The listed applicant is Luv N' Care, Ltd.. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K092494. The device is classified under product code KKO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL FILLED GUM SOOTHER?

GEL FILLED GUM SOOTHER is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Luv N' Care, Ltd.. The 510(k) number is K092494.

When did GEL FILLED GUM SOOTHER receive FDA 510(k) clearance?

GEL FILLED GUM SOOTHER received FDA 510(k) clearance on 2010-03-01, under 510(k) number K092494.

Who is the listed applicant for GEL FILLED GUM SOOTHER?

The FDA 510(k) record lists Luv N' Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEL FILLED GUM SOOTHER?

The FDA product code for GEL FILLED GUM SOOTHER is KKO.

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Other records listing Luv N' Care, Ltd. 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.

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Related Devices (Code: KKO)

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.

K123855WATER-FILLED TEETHERSolid Toys Ind. , Ltd.K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.K092025FLUID FILLED TEETHER - GELKids IIK093266MAM COOLERMam International AGK092781MAM TWISTERMam International AGK093370FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.

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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