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 Knife, Ophthalmic
510(k) Number K110166
Device Name CLEARCUT S SAFETY KNIFE
Applicant
ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Applicant Contact TONYA MORGAN
Correspondent
ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Correspondent Contact TONYA MORGAN
Regulation Number886.4350
Classification Product Code
HNN  
Date Received01/20/2011
Decision Date 05/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-