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FDA 510(k) Application Details - K053493
Device Classification Name
Ring, Teething, Fluid-Filled
More FDA Info for this Device
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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More FDA Info for this Product Code
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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