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FDA 510(k)

UFI GEL HARD C

K-Number: K030916 · 2003-06-19

ApplicantVoco GmbH
Decision Date2003-06-19
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UFI GEL HARD C is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K030916. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UFI GEL HARD C?

UFI GEL HARD C is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is Voco GmbH. The 510(k) number is K030916.

When did UFI GEL HARD C receive FDA 510(k) clearance?

UFI GEL HARD C received FDA 510(k) clearance on 2003-06-19, under 510(k) number K030916.

Who is the listed applicant for UFI GEL HARD C?

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

What is the FDA product code for UFI GEL HARD C?

The FDA product code for UFI GEL HARD C is EBI.

Other records listing Voco GmbH as applicant

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Related Devices (Code: EBI)

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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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