GR Splint Resin System— 510(k) K211415
Substantially EquivalentPro3Dure Medical GmbH
FDA 510(k) clearance K211415 for GR Splint Resin System, Substantially Equivalent on 2021-10-21. Applicant: Pro3Dure Medical GmbH.
Clearance details
- Applicant
- Pro3Dure Medical GmbH
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iserlohn, DE
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.