FDA 510(k) Application Details - K092910

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K092910
Device Name Ring, Teething, Fluid-Filled
Applicant QUALIMAN INDUSTRIAL CO., LTD
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE, CO 80121 US
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Contact Kevin Walls
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 09/22/2009
Decision Date 12/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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