ZF 720— 510(k) K132551

Substantially Equivalent

Umbel Corporation

FDA 510(k) clearance K132551 for ZF 720, Substantially Equivalent on 2014-06-30. Applicant: Umbel Corporation.

Clearance details

Applicant
Umbel Corporation
Product code
Code FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Diamond Bar, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

Source: openFDA MAUDE database, through . 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.