K952247

Substantially Equivalent

BURNSHIELD TRAUMA DRESSING

Applicant
Golightly International Corp.
Product code
MGQ
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hingham, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MGQ

product code MGQ
Death
16
Total
16

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.