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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 K163029
Device Name Hydris™ Oral Rinse
Applicant
Biopharm Consult, LLC
5609 Hard Rock Place
Henrico,  VA  23230
Applicant Contact DAVID S. JOHNSON
Correspondent
Biopharm Consult, LLC
5609 Hard Rock Place
Henrico,  VA  23230
Correspondent Contact DAVID S. JOHNSON
Classification Product Code
LFD  
Date Received10/31/2016
Decision Date 06/19/2017
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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