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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Teething, Fluid-Filled
510(k) Number K053493
Device Name BERRY FRUITY TEETHER
Applicant
EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA,  OH  45377
Applicant Contact RUBEN D COLMENARES
Correspondent
EVENFLO COMPANY, INC.
707 CROSSROADS COURT
VANDALIA,  OH  45377
Correspondent Contact RUBEN D COLMENARES
Regulation Number872.5550
Classification Product Code
KKO  
Date Received12/15/2005
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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