FDA 510(k) Application Details - K053493

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K053493
Device Name Ring, Teething, Fluid-Filled
Applicant EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA, OH 45377 US
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Contact RUBEN D COLMENARES
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 12/15/2005
Decision Date 02/22/2006
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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