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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 K051486
Device Name NORWOOD ABBEY CENTURION SES EPIKERATOME
Applicant
Norwood Abbey , Ltd.
63 Wells Rd.
Chelsea Hgts., Victoria,  AU 3196
Applicant Contact PAUL CLARK
Correspondent
Norwood Abbey , Ltd.
63 Wells Rd.
Chelsea Hgts., Victoria,  AU 3196
Correspondent Contact PAUL CLARK
Regulation Number886.4370
Classification Product Code
HNO  
Date Received06/06/2005
Decision Date 07/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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