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FDA 510(k)

WATER FILLED GUM SOOTHER

K-Number: K981202 · 1998-06-16

ApplicantCorium Corp.
Decision Date1998-06-16
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WATER FILLED GUM SOOTHER is the device name listed in this FDA 510(k) record. The listed applicant is Corium Corp.. It received FDA 510(k) clearance on 1998-06-16 under 510(k) number K981202. 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 GUM SOOTHER?

WATER FILLED GUM SOOTHER is a medical device that received FDA 510(k) clearance on 1998-06-16. The listed applicant is Corium Corp.. The 510(k) number is K981202.

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

WATER FILLED GUM SOOTHER received FDA 510(k) clearance on 1998-06-16, under 510(k) number K981202.

Who is the listed applicant for WATER FILLED GUM SOOTHER?

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

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

The FDA product code for WATER FILLED GUM SOOTHER 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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