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FDA 510(k)

LAD (EPITURE EASYTOUCH), MODEL LAD-08

K-Number: K033962 · 2004-02-20

ApplicantNorwood Abbey , Ltd.
Decision Date2004-02-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAD (EPITURE EASYTOUCH), MODEL LAD-08 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 2004-02-20 under 510(k) number K033962. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAD (EPITURE EASYTOUCH), MODEL LAD-08?

LAD (EPITURE EASYTOUCH), MODEL LAD-08 is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Norwood Abbey , Ltd.. The 510(k) number is K033962.

When did LAD (EPITURE EASYTOUCH), MODEL LAD-08 receive FDA 510(k) clearance?

LAD (EPITURE EASYTOUCH), MODEL LAD-08 received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033962.

Who is the listed applicant for LAD (EPITURE EASYTOUCH), MODEL LAD-08?

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 LAD (EPITURE EASYTOUCH), MODEL LAD-08?

The FDA product code for LAD (EPITURE EASYTOUCH), MODEL LAD-08 is GEX. This falls under the Gastroenterology category.

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.

K051486NORWOOD ABBEY CENTURION SES EPIKERATOMEK042810CENTURION SES EPIKERATOMEK021222LAD, MODEL LAD-01

Related Devices (Code: GEX)

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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Official Source

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

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