FDA 510(k) Application Details - K093642

Device Classification Name Saliva, Artificial

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510(K) Number K093642
Device Name Saliva, Artificial
Applicant INVADO PHARMACEUTICALS
25 RAVENNA DRIVE
POMONA, NY 10970 US
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Contact EDWARD D KOBUS
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 11/24/2009
Decision Date 12/11/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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