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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K001144
Device Name ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
Applicant
Lasersight Technologies, Inc.
3300 University Blvd.
Suite 140
Winter Park,  FL  32792
Applicant Contact SAM MIRZA
Correspondent
Lasersight Technologies, Inc.
3300 University Blvd.
Suite 140
Winter Park,  FL  32792
Correspondent Contact SAM MIRZA
Regulation Number886.4370
Classification Product Code
HNO  
Date Received04/10/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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