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FDA 510(k)

WILOSN-COOK BILIARY DILATION BALLOON

K-Number: K040800 · 2004-06-25

Decision Date2004-06-25
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILOSN-COOK BILIARY DILATION BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2004-06-25 under 510(k) number K040800. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILOSN-COOK BILIARY DILATION BALLOON?

WILOSN-COOK BILIARY DILATION BALLOON is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K040800.

When did WILOSN-COOK BILIARY DILATION BALLOON receive FDA 510(k) clearance?

WILOSN-COOK BILIARY DILATION BALLOON received FDA 510(k) clearance on 2004-06-25, under 510(k) number K040800.

Who is the listed applicant for WILOSN-COOK BILIARY DILATION BALLOON?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WILOSN-COOK BILIARY DILATION BALLOON?

The FDA product code for WILOSN-COOK BILIARY DILATION BALLOON is FGE.

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.

Other records listing Wilson-Cook Medical, Inc. 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.

View all 122 devices →

Related Devices (Code: FGE)

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.

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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