510(k) K172909— ELEVARE, PERFECTIO 4

Substantially Equivalent

Omm Imports D/B/A Zero Gravity

Clearance details

Applicant
Omm Imports D/B/A Zero Gravity
Product code
Code OHS
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Doral, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OHS

product code OHS
Other
1
Total
1

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.