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 K965052
Device Name D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
Applicant
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Applicant Contact RICK MAIN
Correspondent
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Correspondent Contact RICK MAIN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/18/1996
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-