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FDA 510(k)

NORWOOD ABBEY CENTURION SES EPIKERATOME

K-Number: K051486 · 2005-07-06

ApplicantNorwood Abbey , Ltd.
Decision Date2005-07-06
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NORWOOD ABBEY CENTURION SES EPIKERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Norwood Abbey , Ltd.. It received FDA 510(k) clearance on 2005-07-06 under 510(k) number K051486. 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 NORWOOD ABBEY CENTURION SES EPIKERATOME?

NORWOOD ABBEY CENTURION SES EPIKERATOME is a medical device that received FDA 510(k) clearance on 2005-07-06. The listed applicant is Norwood Abbey , Ltd.. The 510(k) number is K051486.

When did NORWOOD ABBEY CENTURION SES EPIKERATOME receive FDA 510(k) clearance?

NORWOOD ABBEY CENTURION SES EPIKERATOME received FDA 510(k) clearance on 2005-07-06, under 510(k) number K051486.

Who is the listed applicant for NORWOOD ABBEY CENTURION SES EPIKERATOME?

The FDA 510(k) record lists Norwood Abbey , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORWOOD ABBEY CENTURION SES EPIKERATOME?

The FDA product code for NORWOOD ABBEY CENTURION SES EPIKERATOME is HNO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Norwood Abbey , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042810CENTURION SES EPIKERATOMEK033962LAD (EPITURE EASYTOUCH), MODEL LAD-08K021222LAD, MODEL LAD-01

Related Devices (Code: HNO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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.

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