MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING— 510(k) K950032

Substantially Equivalent

Brennen Medical, Inc.

FDA 510(k) clearance K950032 for MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING, Substantially Equivalent on 1995-06-28. Applicant: Brennen Medical, Inc..

Clearance details

Applicant: Brennen Medical, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 1995-01-04
Decision date: 1995-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.