L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE— 510(k) K053613

Substantially Equivalent

Theo Manufacturing BV

FDA 510(k) clearance K053613 for L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE, Substantially Equivalent on 2007-07-25. Applicant: Theo Manufacturing BV.

Clearance details

Applicant: Theo Manufacturing BV
Product code: Code FRO
Advisory panel: Unknown
Date received: 2005-12-27
Decision date: 2007-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bailey, CO, 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.