DeviceClearance

K141712

Substantially Equivalent

KIMGUARD ONE STEP STERILIZATION WRAP

Applicant
Halyard Health
Product code
FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
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.