FDA 510(k)

UFI GEL C

K-Number: K974772 · 1998-02-10

Decision Date1998-02-10

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UFI GEL 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 1998-02-10 under 510(k) number K974772. 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 C?

UFI GEL C is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Voco GmbH. The 510(k) number is K974772.

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

UFI GEL C received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974772.

Who is the listed applicant for UFI GEL 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 C?

The FDA product code for UFI GEL C is EBI.

Other records listing Voco GmbH as applicant

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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.