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 K123888
Device Name Z CARTRIDGE IOL DELIVERY SYSTEM
Applicant
AAREN SCIENTIFIC, INC
4290 E. BRICKELL ST. BLDG A
ONTARIO,  CA  91761
Applicant Contact ROBERT K SHEEHAN
Correspondent
AAREN SCIENTIFIC, INC
4290 E. BRICKELL ST. BLDG A
ONTARIO,  CA  91761
Correspondent Contact ROBERT K SHEEHAN
Regulation Number886.4300
Classification Product Code
MSS  
Date Received12/18/2012
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-