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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 K032978
Device Name MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
Applicant
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH,  GA  30097
Applicant Contact PENNY NORTHCUTT
Correspondent
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH,  GA  30097
Correspondent Contact PENNY NORTHCUTT
Regulation Number886.4370
Classification Product Code
HNO  
Subsequent Product Code
HOG  
Date Received09/24/2003
Decision Date 10/20/2003
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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