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 K093642
Device Name NEUTRASAL
Applicant
Invado Pharmaceuticals
25 Ravenna Dr.
Pomona,  NY  10970
Applicant Contact EDWARD D KOBUS
Correspondent
Invado Pharmaceuticals
25 Ravenna Dr.
Pomona,  NY  10970
Correspondent Contact EDWARD D KOBUS
Classification Product Code
LFD  
Date Received11/24/2009
Decision Date 12/11/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-