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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 K181134
Device Name G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
Applicant
Sunstar Americas Inc
301 E. Central Road
Schaumburg,  IL  60195
Applicant Contact Liz Bastian
Correspondent
Sunstar Americas Inc
301 E. Central Road
Schaumburg,  IL  60195
Correspondent Contact Liz Bastian
Classification Product Code
LFD  
Date Received04/30/2018
Decision Date 07/13/2018
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
Recalls CDRH Recalls
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