UNITE BIOMATRIX— 510(k) K071425

Substantially Equivalent

Pegasus Biologics, Inc.

FDA 510(k) clearance K071425 for UNITE BIOMATRIX, Substantially Equivalent on 2007-06-20. Applicant: Pegasus Biologics, Inc..

Clearance details

Applicant: Pegasus Biologics, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2007-05-23
Decision date: 2007-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.