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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
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