FDA 510(k)

DUODERM HYDROACTIVE GEL WOUND DRESSING

K-Number: K990368 · 1999-03-26

ApplicantConvatec, A Bristol-Myers Squibb Co.

Decision Date1999-03-26

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

DUODERM HYDROACTIVE GEL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. It received FDA 510(k) clearance on 1999-03-26 under 510(k) number K990368. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUODERM HYDROACTIVE GEL WOUND DRESSING?

DUODERM HYDROACTIVE GEL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1999-03-26. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. The 510(k) number is K990368.

When did DUODERM HYDROACTIVE GEL WOUND DRESSING receive FDA 510(k) clearance?

DUODERM HYDROACTIVE GEL WOUND DRESSING received FDA 510(k) clearance on 1999-03-26, under 510(k) number K990368.

Who is the listed applicant for DUODERM HYDROACTIVE GEL WOUND DRESSING?

The FDA 510(k) record lists Convatec, A Bristol-Myers Squibb Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUODERM HYDROACTIVE GEL WOUND DRESSING?

The FDA product code for DUODERM HYDROACTIVE GEL WOUND DRESSING is MGQ.

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Other records listing Convatec, A Bristol-Myers Squibb Co. 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.