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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 K990227
Device Name ULTRASHAPER KERATOME
Applicant
LASERSIGHT TECHNOLOGIES, INC.
3300 UNIVERSITY BLVD.
SUITE 140
WINTER PARK,  FL  32792
Applicant Contact MICHAEL P DAYTON
Correspondent
LASERSIGHT TECHNOLOGIES, INC.
3300 UNIVERSITY BLVD.
SUITE 140
WINTER PARK,  FL  32792
Correspondent Contact MICHAEL P DAYTON
Regulation Number886.4370
Classification Product Code
HNO  
Date Received01/25/1999
Decision Date 01/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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