FDA 510(k)

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

K-Number: K032978 · 2003-10-20

Decision Date2003-10-20

Product CodeHNO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Vision Corporation. It received FDA 510(k) clearance on 2003-10-20 under 510(k) number K032978. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME?

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME is a medical device that received FDA 510(k) clearance on 2003-10-20. The listed applicant is Ciba Vision Corporation. The 510(k) number is K032978.

When did MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME receive FDA 510(k) clearance?

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME received FDA 510(k) clearance on 2003-10-20, under 510(k) number K032978.

Who is the listed applicant for MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME?

The FDA 510(k) record lists Ciba Vision Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME?

The FDA product code for MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME is HNO.

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Other records listing Ciba Vision Corporation as applicant

K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL K113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC K083216CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K073459CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES K072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES K062262CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

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Related Devices (Code: HNO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.