CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray

Saliva, Artificial

OraLabs, Inc.

The following data is part of a premarket notification filed by Oralabs, Inc. with the FDA for Cvs Health Dry Mouth Spray, Oralabs Dry Mouth Spray.

Pre-market Notification Details

Device IDK181839
501k NumberK181839
Device Name:CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
ClassificationSaliva, Artificial
Applicant OraLabs, Inc. 18685 East Plaza Drive Parker,  CO  80134
ContactGary Schlatter
CorrespondentTeresa Purdue
OraLabs, Inc. 18685 East Plaza Drive Parker,  CO  80134
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-11
Decision Date2019-11-21

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