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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 K043150
Device Name AMADEUS II EPIKERATOME
Applicant
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
13 RED FOX LANE
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
13 RED FOX LANE
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.4370
Classification Product Code
HNO  
Date Received11/15/2004
Decision Date 01/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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