K231793

Substantially Equivalent

RODIN 3D Resin SPLINT, Hard/Flex

Applicant
Belport Company, Inc., Gingi-Pak
Product code
MQC
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Camarillo, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC
Injury
377
Total
377

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.