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 Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K113852
Device Name BAUSCH & LOMB IOL INJECTOR
Applicant
Bausch & Lomb, Inc.
30 Enterprise Suite 450
Alusi Vuejo,  CA  92656
Applicant Contact JASON SMITH
Correspondent
Bausch & Lomb, Inc.
30 Enterprise Suite 450
Alusi Vuejo,  CA  92656
Correspondent Contact JASON SMITH
Regulation Number886.4300
Classification Product Code
MSS  
Date Received12/29/2011
Decision Date 09/28/2012
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
-
-