RETRO-TECH DRESSING— 510(k) K060832

Substantially Equivalent

Retro-Tech, LLC

FDA 510(k) clearance K060832 for RETRO-TECH DRESSING, Substantially Equivalent on 2007-03-13. Applicant: Retro-Tech, LLC.

Clearance details

Applicant: Retro-Tech, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2006-03-27
Decision date: 2007-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.