FDA 510(k) Application Details - K062653

Device Classification Name Saliva, Artificial

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510(K) Number K062653
Device Name Saliva, Artificial
Applicant PARNELL PHARMACEUTICALS, INC.
1525 FRANCISCO BLVD., STE. 15
SAN RAFAEL, CA 94901 US
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Contact FRANCIS W PARNELL
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 09/07/2006
Decision Date 10/27/2006
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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