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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K121555
Device Name CENTURION VISION SYSTEM
Applicant
ALCON LABORATORIES, INC.
15800 alton parkway
irvine,  CA  92623
Contact charles ogbonna
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/25/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-