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 Mouthguard, Prescription
510(k) Number K190107
Device Name VeriSplint
Applicant
Whip Mix Corporation
361 Farmington Avenue
Louisville,  KY  40217
Applicant Contact John Waters
Correspondent
Whip Mix Corporation
361 Farmington Avenue
Louisville,  KY  40217
Correspondent Contact John Waters
Classification Product Code
MQC  
Subsequent Product Code
EBI  
Date Received01/22/2019
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-