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FDA 510(k)

TYCO BABY SESAME STREET SOFT TEETHER

K-Number: K963912 · 1996-11-06

ApplicantRegu-Tech Assoc., Inc.
Decision Date1996-11-06
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TYCO BABY SESAME STREET SOFT TEETHER is the device name listed in this FDA 510(k) record. The listed applicant is Regu-Tech Assoc., Inc.. It received FDA 510(k) clearance on 1996-11-06 under 510(k) number K963912. 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 TYCO BABY SESAME STREET SOFT TEETHER?

TYCO BABY SESAME STREET SOFT TEETHER is a medical device that received FDA 510(k) clearance on 1996-11-06. The listed applicant is Regu-Tech Assoc., Inc.. The 510(k) number is K963912.

When did TYCO BABY SESAME STREET SOFT TEETHER receive FDA 510(k) clearance?

TYCO BABY SESAME STREET SOFT TEETHER received FDA 510(k) clearance on 1996-11-06, under 510(k) number K963912.

Who is the listed applicant for TYCO BABY SESAME STREET SOFT TEETHER?

The FDA 510(k) record lists Regu-Tech Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYCO BABY SESAME STREET SOFT TEETHER?

The FDA product code for TYCO BABY SESAME STREET SOFT TEETHER is KKO.

Related Clinical Trials

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Other records listing Regu-Tech Assoc., Inc. 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.

K971228FEMTEX 100% COTTON TAMPONSK970232FEMTEX 100% COTTON DENTLE TOUCH TAMPONS

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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