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FDA 510(k) Application Details - K110615
Device Classification Name
Ring, Teething, Fluid-Filled
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510(K) Number
K110615
Device Name
Ring, Teething, Fluid-Filled
Applicant
BEBE TOYS MANUFACTORY LTD.
34 MCNAMARA STREET
STOUGHTON, MA 02072 US
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Contact
PAUL A WARE
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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
03/03/2011
Decision Date
12/02/2011
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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