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 K123202
Device Name PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
Applicant
COOPERVISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton,  CA  94588
Applicant Contact KARIN GASTINEAU
Correspondent
COOPERVISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton,  CA  94588
Correspondent Contact KARIN GASTINEAU
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received10/12/2012
Decision Date 05/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-