Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Saliva, Artificial
510(k) Number K181839
Device Name CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
Applicant
Oralabs, Inc.
18685 E. Plz. Dr.
Parker,  CO  80134
Applicant Contact Gary Schlatter
Correspondent
Oralabs, Inc.
18685 E. Plz. Dr.
Parker,  CO  80134
Correspondent Contact Teresa Purdue
Classification Product Code
LFD  
Date Received07/11/2018
Decision Date 11/21/2019
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
-
-