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 Media, Corneal Storage
510(k) Number K894162
Device Name OPTISOL
Applicant
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact MCGARVEY
Correspondent
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact MCGARVEY
Classification Product Code
LYX  
Date Received06/14/1989
Decision Date 01/12/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-