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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 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact TONYA MORGAN
Correspondent
Alcon Research, Ltd.
6201 S. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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