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

Name: FDA 510(k) clearance K033869
Creator: U.S. Food and Drug Administration
Published: 2004-05-17

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.. Device class: Unclassified.

Clearance details

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

Download summary PDF View on FDA.gov ↗

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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.