FDA 510(k) Application Details - K024148

Device Classification Name Saliva, Artificial

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510(K) Number K024148
Device Name Saliva, Artificial
Applicant SINCLAIR PHARMACEUTICALS, LTD.
BOROUGH RD.
GODALMING, SURREY GU7 2AB GB
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Contact DENISE SWIFT
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 12/16/2002
Decision Date 09/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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