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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 K042810
Device Name 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 Received10/12/2004
Decision Date 10/28/2004
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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