FDA 510(k) Application Details - K123855

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K123855
Device Name Ring, Teething, Fluid-Filled
Applicant SOLID TOYS IND. LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 12/14/2012
Decision Date 05/24/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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