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FDA 510(k)

WATER-FILLED TEETHER

K-Number: K123855 · 2013-05-24

ApplicantSolid Toys Ind. , Ltd.
Decision Date2013-05-24
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WATER-FILLED TEETHER is the device name listed in this FDA 510(k) record. The listed applicant is Solid Toys Ind. , Ltd.. It received FDA 510(k) clearance on 2013-05-24 under 510(k) number K123855. 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 WATER-FILLED TEETHER?

WATER-FILLED TEETHER is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Solid Toys Ind. , Ltd.. The 510(k) number is K123855.

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

WATER-FILLED TEETHER received FDA 510(k) clearance on 2013-05-24, under 510(k) number K123855.

Who is the listed applicant for WATER-FILLED TEETHER?

The FDA 510(k) record lists Solid Toys Ind. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATER-FILLED TEETHER?

The FDA product code for WATER-FILLED TEETHER 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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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.

K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.K092025FLUID FILLED TEETHER - GELKids IIK093266MAM 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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