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 Intraocular Lens
510(k) Number K914311
Device Name CHIROFLEX II LENS MICROSERT(TM)
Applicant
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact CAROL L PATTERSON
Correspondent
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact CAROL L PATTERSON
Regulation Number886.3600
Classification Product Code
HQL  
Date Received09/26/1991
Decision Date 01/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-