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FDA 510(k)

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

K-Number: K110615 · 2011-12-02

ApplicantBebe Toys Manufactory , Ltd.
Decision Date2011-12-02
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bebe Toys Manufactory , Ltd.. It received FDA 510(k) clearance on 2011-12-02 under 510(k) number K110615. 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 WITH HANDLE?

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE is a medical device that received FDA 510(k) clearance on 2011-12-02. The listed applicant is Bebe Toys Manufactory , Ltd.. The 510(k) number is K110615.

When did WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE receive FDA 510(k) clearance?

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE received FDA 510(k) clearance on 2011-12-02, under 510(k) number K110615.

Who is the listed applicant for WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE?

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

What is the FDA product code for WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE?

The FDA product code for WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE is KKO.

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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.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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