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FDA 510(k)

FLUID FILLED TEETHER - GEL

K-Number: K092025 · 2011-01-27

ApplicantKids II
Decision Date2011-01-27
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUID FILLED TEETHER - GEL is the device name listed in this FDA 510(k) record. The listed applicant is Kids II. It received FDA 510(k) clearance on 2011-01-27 under 510(k) number K092025. 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 FLUID FILLED TEETHER - GEL?

FLUID FILLED TEETHER - GEL is a medical device that received FDA 510(k) clearance on 2011-01-27. The listed applicant is Kids II. The 510(k) number is K092025.

When did FLUID FILLED TEETHER - GEL receive FDA 510(k) clearance?

FLUID FILLED TEETHER - GEL received FDA 510(k) clearance on 2011-01-27, under 510(k) number K092025.

Who is the listed applicant for FLUID FILLED TEETHER - GEL?

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

What is the FDA product code for FLUID FILLED TEETHER - GEL?

The FDA product code for FLUID FILLED TEETHER - GEL is KKO.

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 Kids II 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.

K082824FLUID FILLED TEETHER

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.K093266MAM COOLERMam International AGK092781MAM TWISTERMam International AGK092494GEL FILLED GUM SOOTHERLuv N' Care, Ltd.K093370FU 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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