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 K162167
Device Name Caphosol Artifical Saliva Tablets
Applicant
EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead,  GB HP2-4TZ
Applicant Contact Paul Davisson
Correspondent
Delphi Consulting Group
11874 South Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J. Harvey Knauss
Classification Product Code
LFD  
Date Received08/03/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-