GR-17 Resin System
K-Number: K201827 · 2020-11-05
ApplicantPro3Dure Medical GmbH
Decision Date2020-11-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GR-17 Resin System is a medical device manufactured by Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2020-11-05 under approval number K201827. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GR-17 Resin System?
GR-17 Resin System is a medical device that received FDA 510(k) clearance on 2020-11-05. It is manufactured by Pro3Dure Medical GmbH. The 510(k) number is K201827.
When was GR-17 Resin System approved by the FDA?
GR-17 Resin System received FDA 510(k) clearance on 2020-11-05, under approval number K201827.
What company makes GR-17 Resin System?
GR-17 Resin System is manufactured by Pro3Dure Medical GmbH.
What is the FDA product code for GR-17 Resin System?
The FDA product code for GR-17 Resin System is EBG.
Related Clinical Trials
Other Devices by Pro3Dure Medical GmbH
Related Devices (Code: EBG)
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.