FDA 510(k) Application Details - K093370

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K093370
Device Name Ring, Teething, Fluid-Filled
Applicant FU HONG INDUSTRIES LTD.
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE, CO 80121 US
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Contact KEVIN WALLS, RAC
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 10/29/2009
Decision Date 01/21/2010
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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