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FDA 510(k)

VYGON LEADER-FLEX

K-Number: K052564 · 2006-04-05

ApplicantVygon Corp.
Decision Date2006-04-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON LEADER-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 2006-04-05 under 510(k) number K052564. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYGON LEADER-FLEX?

VYGON LEADER-FLEX is a medical device that received FDA 510(k) clearance on 2006-04-05. The listed applicant is Vygon Corp.. The 510(k) number is K052564.

When did VYGON LEADER-FLEX receive FDA 510(k) clearance?

VYGON LEADER-FLEX received FDA 510(k) clearance on 2006-04-05, under 510(k) number K052564.

Who is the listed applicant for VYGON LEADER-FLEX?

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

What is the FDA product code for VYGON LEADER-FLEX?

The FDA product code for VYGON LEADER-FLEX is FOZ.

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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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