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510(k) Data Aggregation

K Number

Device Name

FLUID-FILLED TEETHER

Manufacturer

QUALIMAN INDUSTRIAL CO., LTD

Date Cleared

2009-12-18

(87 days)

Product Code

KKO

Regulation Number

872.5550

Why did this record match?

Applicant Name (Manufacturer) :

QUALIMAN INDUSTRIAL CO., LTD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Device Description

Not Found

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