COMFEEL POWDER— 510(k) K834343

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K834343 for COMFEEL POWDER, Substantially Equivalent on 1984-11-08. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code KOZ
Advisory panel: General, Plastic Surgery
Date received: 1983-12-12
Decision date: 1984-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KOZ

product code KOZ

Other: 1
Total: 1

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.