510(k) K032978

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

K032978 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME". The FDA issued a decision of Substantially Equivalent on October 20, 2003. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.