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510(k) K032978

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME by Ciba Vision Corporation — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2003
Date Received
September 24, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

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