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FDA 510(k)

DUAL YELLOW LASER, MODEL DUAL YELLOW D10B

K-Number: K032397 · 2004-05-27

ApplicantNorseld Pty., Ltd.
Decision Date2004-05-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUAL YELLOW LASER, MODEL DUAL YELLOW D10B is the device name listed in this FDA 510(k) record. The listed applicant is Norseld Pty., Ltd.. It received FDA 510(k) clearance on 2004-05-27 under 510(k) number K032397. 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 DUAL YELLOW LASER, MODEL DUAL YELLOW D10B?

DUAL YELLOW LASER, MODEL DUAL YELLOW D10B is a medical device that received FDA 510(k) clearance on 2004-05-27. The listed applicant is Norseld Pty., Ltd.. The 510(k) number is K032397.

When did DUAL YELLOW LASER, MODEL DUAL YELLOW D10B receive FDA 510(k) clearance?

DUAL YELLOW LASER, MODEL DUAL YELLOW D10B received FDA 510(k) clearance on 2004-05-27, under 510(k) number K032397.

Who is the listed applicant for DUAL YELLOW LASER, MODEL DUAL YELLOW D10B?

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

What is the FDA product code for DUAL YELLOW LASER, MODEL DUAL YELLOW D10B?

The FDA product code for DUAL YELLOW LASER, MODEL DUAL YELLOW D10B is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Norseld Pty., 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.

K023899DUAL YELLOW LASER, MODEL D10B

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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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