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 K981693
Device Name SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
Applicant
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Applicant Contact DENISE E SPELLMAN
Correspondent
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Correspondent Contact DENISE E SPELLMAN
Classification Product Code
LFD  
Date Received05/13/1998
Decision Date 08/06/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-