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FDA 510(k)

CENTURION SES EPIKERATOME

K-Number: K042810 · 2004-10-28

ApplicantNorwood Abbey , Ltd.
Decision Date2004-10-28
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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 2004-10-28 under 510(k) number K042810. 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 CENTURION SES EPIKERATOME?

CENTURION SES EPIKERATOME is a medical device that received FDA 510(k) clearance on 2004-10-28. The listed applicant is Norwood Abbey , Ltd.. The 510(k) number is K042810.

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

CENTURION SES EPIKERATOME received FDA 510(k) clearance on 2004-10-28, under 510(k) number K042810.

Who is the listed applicant for 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 CENTURION SES EPIKERATOME?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K051486NORWOOD ABBEY CENTURION 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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