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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K173808
Device Name Voutia™
Applicant
Jeffrey Ward Cash, Dds
10149 Bon Air Crest Dr.
North Chesterfield,  VA  23235
Applicant Contact Jeffrey Ward Cash
Correspondent
Jeffrey Ward Cash, Dds
10149 Bon Air Crest Dr.
North Chesterfield,  VA  23235
Correspondent Contact Jeffrey Ward Cash
Classification Product Code
LFD  
Date Received12/15/2017
Decision Date 07/27/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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