3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214— 510(k) K982638

Substantially Equivalent

Innovative Technologies , Ltd.

FDA 510(k) clearance K982638 for 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214, Substantially Equivalent on 1998-08-21. Applicant: Innovative Technologies , Ltd..

Clearance details

Applicant: Innovative Technologies , Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 1998-07-29
Decision date: 1998-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winsford, Cheshire, GB

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Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.