K781574

Substantially Equivalent

PLASTI-PORE SEPTAL BUTTON

Applicant
Richard'S Medical Equip., Inc.
Product code
FZE
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FZE

product code FZE
Injury
138
Total
138

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.