SWEEN WOUN'DRES— 510(k) K983042

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K983042 for SWEEN WOUN'DRES, Substantially Equivalent on 1998-11-25. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-08-31
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Mankato, MN, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.