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 K132593
Device Name CRYSTALSERT DELIVERY SYSTEM
Applicant
Bausch & Lomb
30 Enterprise, Suite 450
Aliso Viejo,  CA  92656 -7115
Applicant Contact YI GAO
Correspondent
Bausch & Lomb
30 Enterprise, Suite 450
Aliso Viejo,  CA  92656 -7115
Correspondent Contact YI GAO
Regulation Number886.4300
Classification Product Code
MSS  
Date Received08/19/2013
Decision Date 09/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-