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FDA 510(k)

AMBU GEL, HYDROGEL BURN DRESSING

K-Number: K010583 · 2001-05-25

ApplicantAmbu, Inc.
Decision Date2001-05-25
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

AMBU GEL, HYDROGEL BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 2001-05-25 under 510(k) number K010583. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU GEL, HYDROGEL BURN DRESSING?

AMBU GEL, HYDROGEL BURN DRESSING is a medical device that received FDA 510(k) clearance on 2001-05-25. The listed applicant is Ambu, Inc.. The 510(k) number is K010583.

When did AMBU GEL, HYDROGEL BURN DRESSING receive FDA 510(k) clearance?

AMBU GEL, HYDROGEL BURN DRESSING received FDA 510(k) clearance on 2001-05-25, under 510(k) number K010583.

Who is the listed applicant for AMBU GEL, HYDROGEL BURN DRESSING?

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

What is the FDA product code for AMBU GEL, HYDROGEL BURN DRESSING?

The FDA product code for AMBU GEL, HYDROGEL BURN DRESSING is MGQ.

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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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