G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

Saliva, Artificial

Sunstar Americas Inc

The following data is part of a premarket notification filed by Sunstar Americas Inc with the FDA for G•u•m Hydral Dry Mouth Oral Gel, G•u•m Hydral Dry Mouth Oral Rinse, G•u•m Hydral Dry Mouth Oral Spray.

Pre-market Notification Details

Device IDK181134
510k NumberK181134
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
ClassificationSaliva, Artificial
Applicant Sunstar Americas Inc 301 E. Central Road Schaumburg,  IL  60195
ContactLiz Bastian
CorrespondentLiz Bastian
Sunstar Americas Inc 301 E. Central Road Schaumburg,  IL  60195
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-30
Decision Date2018-07-13
Summary:summary

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