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 K122663
Device Name ORAMOIST
Applicant
QUANTUM, INC.
7195 LONGVIEW DRIVE
CLEVELAND,  OH  44139
Applicant Contact FRED MA
Correspondent
QUANTUM, INC.
7195 LONGVIEW DRIVE
CLEVELAND,  OH  44139
Correspondent Contact FRED MA
Classification Product Code
LFD  
Date Received08/31/2012
Decision Date 05/30/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-