DeviceClearance

K871071

Substantially Equivalent

OMEGA DORSAL COLUMELLA IMPLANTS

Applicant
Omega Silicone, Inc.
Product code
FZE
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Barbara, CA, 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.