FDA 510(k) Application Details - K123731

Device Classification Name Saliva, Artificial

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510(K) Number K123731
Device Name Saliva, Artificial
Applicant GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
1500 LITTLETON ROAD
PARSIPPANY, NJ 07054 US
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Contact PAUL KRUMM
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 12/05/2012
Decision Date 01/04/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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