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 K972454
Device Name OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14692
Applicant Contact DENNIS HAHN
Correspondent
Bausch & Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14692
Correspondent Contact DENNIS HAHN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/01/1997
Decision Date 08/08/1997
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
-
-