COMFEEL BARRIER CREAM— 510(k) K833569

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K833569 for COMFEEL BARRIER CREAM, Substantially Equivalent on 1983-12-27. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1983-10-12
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.