FDA 510(k) Application Details - K051812

Device Classification Name Saliva, Artificial

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510(K) Number K051812
Device Name Saliva, Artificial
Applicant LABORATOIRES CARILENE S.A.S.
1800 MASSACHUSETTS AVE., NW
WASHINGTON, DC 20036 US
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Contact EMALEE MURPHY
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 07/05/2005
Decision Date 10/21/2005
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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