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FDA 510(k)

FLUID FILLED TEETHERS

K-Number: K031094 · 2003-12-08

Decision Date2003-12-08
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUID FILLED TEETHERS is the device name listed in this FDA 510(k) record. The listed applicant is Royal King Infant Products Co. , Ltd.. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K031094. 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 FLUID FILLED TEETHERS?

FLUID FILLED TEETHERS is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Royal King Infant Products Co. , Ltd.. The 510(k) number is K031094.

When did FLUID FILLED TEETHERS receive FDA 510(k) clearance?

FLUID FILLED TEETHERS received FDA 510(k) clearance on 2003-12-08, under 510(k) number K031094.

Who is the listed applicant for FLUID FILLED TEETHERS?

The FDA 510(k) record lists Royal King Infant Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUID FILLED TEETHERS?

The FDA product code for FLUID FILLED TEETHERS 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.

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.

Official Source

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