DUODERM HYDROACTIVE GEL— 510(k) K973806

Substantially Equivalent for Some Indications

Convatec, A Bristol-Myers Squibb Co.

FDA 510(k) clearance K973806 for DUODERM HYDROACTIVE GEL, Substantially Equivalent for Some Indications on 1997-12-29. Applicant: Convatec, A Bristol-Myers Squibb Co..

Clearance details

Applicant
Convatec, A Bristol-Myers Squibb Co.
Product code
Code MGQ
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Skillman, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MGQ

product code MGQ
Death
16
Total
16

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.