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 lens, contact, (disposable)
510(k) Number K051900
Device Name ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Applicant Contact SUSAN MORRIS
Correspondent
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Correspondent Contact SUSAN MORRIS
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received07/13/2005
Decision Date 08/12/2005
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
-
-