FDA 510(k) Application Details - K091198

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K091198
Device Name Ring, Teething, Fluid-Filled
Applicant ALLIED HILL ENTERPRISES, 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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Date Received 04/24/2009
Decision Date 12/07/2009
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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