Elevate Moisturizing Spray— 510(k) K150074

Substantially Equivalent

Elevate Oral Care

FDA 510(k) clearance K150074 for Elevate Moisturizing Spray, Substantially Equivalent on 2015-06-19. Applicant: Elevate Oral Care.

Clearance details

Applicant
Elevate Oral Care
Product code
Code LFD
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Palm Beach, FL, 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.