CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)— 510(k) K033869

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K033869 for CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.), Substantially Equivalent on 2004-05-17. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2003-12-12
Decision date: 2004-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Mankato, MN, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.