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 unit, phacofragmentation
510(k) Number K121721
Device Name LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
Applicant
ABBOTT MEDICAL OPTICS INC
1700 E. ST. ANDREW PLACE
SANTA ANA,  CA  92705
Applicant Contact ABBAS M BOHRA
Correspondent
ABBOTT MEDICAL OPTICS INC
1700 E. ST. ANDREW PLACE
SANTA ANA,  CA  92705
Correspondent Contact ABBAS M BOHRA
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/12/2012
Decision Date 10/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-