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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 K110615
Device Name WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
Applicant
BEBE TOYS MANUFACTORY LTD.
34 MCNAMARA STREET
STOUGHTON,  MA  02072
Applicant Contact PAUL A WARE
Correspondent
BEBE TOYS MANUFACTORY LTD.
34 MCNAMARA STREET
STOUGHTON,  MA  02072
Correspondent Contact PAUL A WARE
Regulation Number872.5550
Classification Product Code
KKO  
Date Received03/03/2011
Decision Date 12/02/2011
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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