ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX— 510(k) K140367

Substantially Equivalent

Harbor Medtech, Inc.

FDA 510(k) clearance K140367 for ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX, Substantially Equivalent on 2014-09-12. Applicant: Harbor Medtech, Inc..

Clearance details

Applicant: Harbor Medtech, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2014-02-14
Decision date: 2014-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.