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FDA 510(k)

VYGON UMBILICAL CATHETHER INSERTION TRAY

K-Number: K963196 · 1997-09-09

ApplicantVygon Corp.
Decision Date1997-09-09
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON UMBILICAL CATHETHER INSERTION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K963196. 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 UMBILICAL CATHETHER INSERTION TRAY?

VYGON UMBILICAL CATHETHER INSERTION TRAY is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is Vygon Corp.. The 510(k) number is K963196.

When did VYGON UMBILICAL CATHETHER INSERTION TRAY receive FDA 510(k) clearance?

VYGON UMBILICAL CATHETHER INSERTION TRAY received FDA 510(k) clearance on 1997-09-09, under 510(k) number K963196.

Who is the listed applicant for VYGON UMBILICAL CATHETHER INSERTION TRAY?

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 UMBILICAL CATHETHER INSERTION TRAY?

The FDA product code for VYGON UMBILICAL CATHETHER INSERTION TRAY 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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