BIOXTRA MOISTURIZING GEL— 510(k) K072306

Substantially Equivalent

Bio-X Healthcare S.A.

FDA 510(k) clearance K072306 for BIOXTRA MOISTURIZING GEL, Substantially Equivalent on 2007-11-15. Applicant: Bio-X Healthcare S.A..

Clearance details

Applicant
Bio-X Healthcare S.A.
Product code
Code LFD
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LFD

product code LFD
Death
3
Total
3

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.