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FDA 510(k)

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS

K-Number: K013587 · 2002-05-14

ApplicantBabies Best, Inc.
Decision Date2002-05-14
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Babies Best, Inc.. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K013587. 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 BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS?

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Babies Best, Inc.. The 510(k) number is K013587.

When did BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS receive FDA 510(k) clearance?

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS received FDA 510(k) clearance on 2002-05-14, under 510(k) number K013587.

Who is the listed applicant for BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS?

The FDA 510(k) record lists Babies Best, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS?

The FDA product code for BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS 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.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.

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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