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FDA 510(k)

GALILEO DISPOSABLE ENDOSCOPES

K-Number: K981928 · 1998-08-06

ApplicantGalileo Electro-Optics Corp.
Decision Date1998-08-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GALILEO DISPOSABLE ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Galileo Electro-Optics Corp.. It received FDA 510(k) clearance on 1998-08-06 under 510(k) number K981928. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO DISPOSABLE ENDOSCOPES?

GALILEO DISPOSABLE ENDOSCOPES is a medical device that received FDA 510(k) clearance on 1998-08-06. The listed applicant is Galileo Electro-Optics Corp.. The 510(k) number is K981928.

When did GALILEO DISPOSABLE ENDOSCOPES receive FDA 510(k) clearance?

GALILEO DISPOSABLE ENDOSCOPES received FDA 510(k) clearance on 1998-08-06, under 510(k) number K981928.

Who is the listed applicant for GALILEO DISPOSABLE ENDOSCOPES?

The FDA 510(k) record lists Galileo Electro-Optics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALILEO DISPOSABLE ENDOSCOPES?

The FDA product code for GALILEO DISPOSABLE ENDOSCOPES is GCJ.

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Other records listing Galileo Electro-Optics Corp. 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.

K962256GALILEO HYSTEROSCOPES AND LAPAROSCOPESK962116GALILEO ENDOSCOPESK934649GALILEO ENDOSCOPESK934707GALILEO ARTHROSCOPESK936280GALILEO ARTHROSCOPESK936279GALILEO ENDOSCOPES

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Related Devices (Code: GCJ)

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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.

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