GR Splint Resin System
K-Number: K211415 · 2021-10-21
ApplicantPro3Dure Medical GmbH
Decision Date2021-10-21
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
GR Splint Resin System is a medical device manufactured by Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2021-10-21 under approval number K211415. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GR Splint Resin System?
GR Splint Resin System is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Pro3Dure Medical GmbH. The 510(k) number is K211415.
When was GR Splint Resin System approved by the FDA?
GR Splint Resin System received FDA 510(k) clearance on 2021-10-21, under approval number K211415.
What company makes GR Splint Resin System?
GR Splint Resin System is manufactured by Pro3Dure Medical GmbH.
What is the FDA product code for GR Splint Resin System?
The FDA product code for GR Splint Resin System is MQC.
Related Clinical Trials
Other Devices by Pro3Dure Medical GmbH
Related Devices (Code: MQC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.