K920293

Substantially Equivalent

DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY

Applicant
Davis & Geck, Inc.
Product code
FLE
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danbury, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE
Malfunction
444
Total
444

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.