FDA 510(k)

DUODERM HYDROACTIVE GEL

K-Number: K973806 · 1997-12-29

ApplicantConvatec, A Bristol-Myers Squibb Co.

Decision Date1997-12-29

Product CodeMGQ

DecisionSubstantially Equivalent for Some Indications

Device Summary

DUODERM HYDROACTIVE GEL 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 1997-12-29 under 510(k) number K973806. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DUODERM HYDROACTIVE GEL?

DUODERM HYDROACTIVE GEL is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. The 510(k) number is K973806.

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

DUODERM HYDROACTIVE GEL received FDA 510(k) clearance on 1997-12-29, under 510(k) number K973806.

Who is the listed applicant for DUODERM HYDROACTIVE GEL?

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?

The FDA product code for DUODERM HYDROACTIVE GEL 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.