PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX— 510(k) K113866

Substantially Equivalent

Brennen Medical, LLC

FDA 510(k) clearance K113866 for PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX, Substantially Equivalent on 2012-03-23. Applicant: Brennen Medical, LLC.

Clearance details

Applicant: Brennen Medical, LLC
Product code: Code KGN
Advisory panel: Unknown
Date received: 2011-12-30
Decision date: 2012-03-23
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.