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 lenses, soft contact, daily wear
510(k) Number K190965
Device Name MyDay
Applicant
CooperVision, Inc.
5870 Stoneridge Drive, Suite 1
Pleasanton,  CA  94588
Applicant Contact Marie Dutton
Correspondent
CooperVision, Inc.
5870 Stoneridge Drive, Suite 1
Pleasanton,  CA  94588
Correspondent Contact Marie Dutton
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/12/2019
Decision Date 04/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-