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FDA 510(k)

BILIARY STENT PROSTHESIS

K-Number: K844384 · 1985-02-14

ApplicantMentor Corp.
Decision Date1985-02-14
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BILIARY STENT PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K844384. 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 BILIARY STENT PROSTHESIS?

BILIARY STENT PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Mentor Corp.. The 510(k) number is K844384.

When did BILIARY STENT PROSTHESIS receive FDA 510(k) clearance?

BILIARY STENT PROSTHESIS received FDA 510(k) clearance on 1985-02-14, under 510(k) number K844384.

Who is the listed applicant for BILIARY STENT PROSTHESIS?

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

What is the FDA product code for BILIARY STENT PROSTHESIS?

The FDA product code for BILIARY STENT PROSTHESIS 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 Mentor 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.

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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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