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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 K163476
Device Name Lubricity
Applicant
You First Services, Incorporated
1576 Sweet Home Rd.
Amherst,  NY  14228
Applicant Contact Jeffrey Eberhard
Correspondent
You First Services, Incorporated
1576 Sweet Home Rd.
Amherst,  NY  14228
Correspondent Contact Jeffrey Eberhard
Classification Product Code
LFD  
Date Received12/12/2016
Decision Date 05/10/2017
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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