FDA 510(k) Application Details - K173237

Device Classification Name Saliva, Artificial

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510(K) Number K173237
Device Name Saliva, Artificial
Applicant Syendgen, Inc.
1420 N. Claremont Blvd. Suite 105D
Claremont, CA 91711 US
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Contact Shenda Baker
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Regulation Number 000.0000

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Classification Product Code LFD
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Date Received 10/05/2017
Decision Date 03/19/2018
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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